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Job Post Information* : Posted Date 3 months ago(2022/11/22 16:19)
Coordinates inbound and outbound logistical operations being accountable for the imports and exports of goods and also information flows supporting these operations. Manages inventory, warehousing operations, regulate warehouse space, including reception, pathway, sampling, dispensing and arrange shipments, and local transportation to ensure an efficient supply of goods. Administers an effective system that meets the organization’s inventory targets through efficient and transparent flow of information and materials, including raw materials, intermediates, finished products and spare parts.   - Oversee warehouse activities and TMs, ensuring all applicable procedures are implemented and making sure the assigned resources are selected, packaged, loaded and/or dispatched safely, timely and efficiency - Promote productivity and safety in warehouse activities, by planning activities and shifts of operators, anticipating needs and workloads - Monitor and control warehouse operations according to HSE practices, cGMP, cGDP compliance and quality policy - Assure visibility of monitoring results for internal stakeholders in a order to contribute for orchestration of the site operations - Review and control records of resources handled according to established processes - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks and suggesting process optimizations or improvements - Ensure that raw materials are tested and dispensed to production according to procedures - Ensure that inventories are made and recorded according to procedures, guaranteeing the identification of product losses and taking correcting actions - Guarantee that equipment is inspected and guarantee proper maintenance and replacement - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations - Analyze warehouse data in order to optimize resources and procedures for continuous improvement - Support in the training of warehouse teams, mainly giving inputs for the elaboration of contents and training goals - Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity. - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with Supply Chain strategic objectives - Monitor own budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
ID
2022-9074
Location
US-NJ-East Windsor
# of Openings
1
Job Family
SUPPLY CHAIN, LOGISTICS & PROCUREMENT
Job Post Information* : Posted Date 2 months ago(2022/12/7 11:12)
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals on a regular basis. Promotes alignment by understanding and communicating business and customers’ needs and requirements through the organization.   - Lead sourcing and procurement activities for specific categories of indirect materials and services to ensure business alignment and guidance, compliance, stakeholder management (internal and external) and optimize categories' spend. - Develop appropriate purchasing strategies for specific categories of indirect materials and services to ensure continuity of supply, increased productivity, reduced costs, right quality levels and regulatory & legal compliance. Proactively seek and suggest improvement opportunities. - Develop Supplier’s relationships and trust and ensure the Company’s values are shared and aligned with Supplier’s values to establish long term relationships with key and strategic suppliers who share values and enable the company to outperform competition. - Provide the organization with important insights on business, market conditions and the competitive landscape aiming at leveraging the global and local markets and differentiated sourcing strategies. - Develop, right size and maintain a robust and sustainable supply base to achieve the procurement goals in terms of financial performance, supplier quality, supply chain efficiency, security and sustainability whilst establishing solid, sustainable and reliable partnerships according to the supplier segmentation. - Establish relationships with the sites' key stakeholders to ensure procurement alignment with their objectives. Share and communicate the procurement strategies of the own portfolio of materials/services, gain feedback and obtain their support and resources to achieve both objectives. Interface with the sites' procurement teams and provide the necessary guidance for the local implementation of the category’s strategies. - Ensured uniform approach to procurement spend in all sites for the respective categories. Enhanced co-operation between category management and local procurement teams leading to optimized performance (financial, compliance and technical). Full alignment in the organization and working towards common goals. - Negotiate purchasing terms and conditions to assure optimized. financial performance of purchased indirect materials and services and ensured compliance with the company's purchasing policy and working capital objectives. - Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner. - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the procurement tasks under her / his responsibility. - Gather relevant data to inform the decision makers regarding complex issues. - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2022-9073
Location
PT-Lisbon
# of Openings
1
Job Family
PROCUREMENT
Job Post Information* : Posted Date 3 months ago(2022/11/18 19:13)
Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Rigorously, efficiently and professionally, execute all production/HSE activities, adhering to all applicable procedures and following instructions received from ascending colleagues. - To execute, with supervision, the production/HSE processes. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Be an advocate for safe operating and high quality performance, alerting ascending colleagues to any potential risks and suggesting production/HSE optimizations or improvements. - Develop and accumulate strong production/HSE knowledge. - Demonstrate professionalism in the workplace. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Be responsible for the safe and efficient operation of various equipment (which may vary according to the Production/HSE Area in which the TM are allocated). - Maintain clean and organized facilities. - Attend and participate fully in all meetings and training to which the TM is invited. - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes. - Suggest and participate in improvements in the area in which the TM is assigned. - Ensure that all equipment is checked and calibrated before use. - Ensure the correct identification and use of equipment (labels, plates, logbooks, etc.). - Prepare samples (according to the Area in which the TM is allocated). - Execute production/HSE tasks correctly in Hovione systems (including but not limited to SAP, LIMS, SchedulePro etc.). - Use the Personal Protective Equipment and keep it in good condition. - Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET). - Collaborate in the revision of any area documents as requested (IOPs, others). - Collaborate in internal and external audits / inspections as requested. - Participate, as required, in the induction and training of new Operators across Hovione, Collaborate in the integration of the transferred Operators from other areas. - Follow all annual performance review requirements, including completion of the self-assessment. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2022-9053
Location
US-NJ-East Windsor
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 3 months ago(2022/11/18 19:12)
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Ensure the effective and proactive flow of information and requests between the QC team and the internal and external (if applicable) stakeholders - Participate in meetings with internal and external customers as representative of analytical area, providing information on the status of activities - Provide collaborative and timely support in the resolution of analytical problems relating to assigned projects / initiatives - Propose and prepare changes to QC procedures or analytical methods for onwards approval and implementation - Assure product specifications are maintained in accordance with appropriate standards and propose revisions as required - Issue and follow-up change controls - Assure good functioning equipment, planning and managing the maintenance, internal calibration plans, reference standards and internal qualifications of designated laboratory instruments - Accurately use and maintain all laboratory information systems, participating in the implementation of lab systems improvements as required - Prepare protocols, reports, QC documentation and review records to ensure compliance with cGMP and HSEE standards - Request quotations and propose the acquisition of instruments, materials and reagents to guarantee the stock control and operation of the laboratories - Manage reserve/retention samples - Initiate events and deviations in the CAPA system in accordance with the required timeframes and in partnership with appropriate colleagues, complete relevant section/s of the event or deviation - Lead and participate in root-cause investigations, guiding colleagues (as required) in the necessary investigative testing, and ensuring appropriate corrective and preventative actions are determined - Determine the root cause of events and deviations based upon the data and information obtained through the investigation, ensuring appropriate corrective and preventative actions are determined - Complete or support the completion/close out of OOS/OOT laboratory deviation investigations and QC incidents - Monitor progress and follow-up corrective and preventative actions - Monitor the status of open events and deviations and provide periodic status reports to QC management - Assess the impact of changes to facilities/systems/equipment/stability and processing of change control documents - Perform periodic checks of laboratory documentation to ensure compliance with applicable operating procedures and identify and implement updates/improvements to current procedures - Be an advocate for safe operating and high-quality performance within the area, alerting the management of the area to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements - Prepare and participate in internal/external audits as requiredSupport the compilation of audit responses for QC - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate - Make quality and timely decisions within the tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
ID
2022-9043
Location
US-NJ-East Windsor
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 3 months ago(2022/11/11 16:45)
Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.   - Promote high-quality work within the team and a mindset of continuous improvement - Advise Team Members when unconformities with Quality or, Regulatory Systems and Tools have been identified and promote corrective actions - Propose new procedures and or policies according to the requirements applicable to the company business and strategy and review existing procedures - Prepare Quality and/or Regulatory Systems and Tools related documentation and training - Participate in Audits/inspections (Internal and of Health Authorities) - Perform other Corporate key activities, such as delivering Corporate Quality or Regulatory KPI’s, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.g., Documentation Management System), CAPA, Change Control, corporate analytical electronic systems, filings, customer support etc.) - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Lead initiatives within group or department, ensuring plan definition and timely execution - Make quality and timely decisions within the Quality and/or Regulatory Systems’ tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with applicable Quality, Regulatory and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) May qualify as internal GMP auditor
ID
2022-9041
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 3 months ago(2022/11/18 17:27)
Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.   Manage the full range of projects in the allocated area and solve complex problems with full autonomy. Project assignment will always be based on business need, however, preferentially, projects assigned will have a higher degree of complexity and more significant business impact including - a high cumulative sales / project cost value - a high project control level - a high customer segmentation level - Effectively supports project TMs and coaches less experienced PMs to enhance company effectiveness and promote achievement of high standards within the organization. - Proactively manage and take responsibility of the scope, cost, time and quality of each project assigned. - Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with industry or Company best practices. - Lead the project team to take decisions and influence key stakeholders with integrity. - Actively influence the project team composition and selection. - Clarify project team roles and responsibilities and enable others to optimize their use of technical, management and leadership skills. - Communicate proactively and effectively internally and externally, building rapport with key stakeholders. - Build and sustain motivation of the project TMs and positive dynamics within the project team. - Give timely and specific feedback to the project TMs regularly, both positive and constructive. - Propose innovative solutions, including processes and tools adjusted to the organization and market needs. - Demonstrate track record in project management. - Solve complex problems with full autonomy. - Make quality and timely decisions based on multiple sources of data and regarding a wide array of subjects. - Manage risk and uncertainty; anticipate and address roadblocks in order to prevent deviations to the goals. - Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization. - Comply with all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2022-9037
Location
PT-Lisbon
# of Openings
1
Job Family
GENERAL MANAGEMENT
Job Post Information* : Posted Date 3 months ago(2022/11/15 14:43)
- Prepare, review or approve analytical test methods to be executed by Analytical areas; - Prepare and review the protocols for work to be excuted in QC Labs; - Prepare and review reports related with work carried out within the QC Laboratory; - Define analytical strategies to allow the resolution of analytical problems detected; - Verify and approve the analyses performed within the Quality Control Production Group whenever necessary; - Support technically the analysts when conducting investigations or troubleshooting in the analytical lab;
ID
2022-9036
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 3 months ago(2022/11/17 15:42)
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs. - To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system. - Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities. - To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures. - To maintain good hygiene and housekeeping within the laboratory. - To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area. - Comply with the high standards in the QC Laboratories. - To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures. - To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories. - Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms. - Assist with audits as required, following the instruction of QC Management. - Undertake any additional tasks to support the laboratory activities as and when required. - Seek out additional information when one feels that the available information is not enough. - Follow all annual performance review requirements, including completion of the self-assessment. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
ID
2022-9035
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 3 months ago(2022/11/2 13:51)
Manage and maintain the compliance of documentation control as per the Company’s Quality System and cGMP Guidelines. In charge of the documentation control function and participates in the daily quality assurance functions. To assist the Director of Quality Assurance in the implementation of cGMP and Quality System, specialized in the documentation control aspects.   - Responsible for the administration of QA Documentation Systems, maintaining the compliance of documentation control for the Hovione-HE group. - Carries out responsibilities in accordance with Hovione policies and procedures, and as per cGMP Guidelines and other regulatory standards, triggering actions if necessary. - Ensures accuracy, completeness, and conformity of the QA document system. - Manages electronic controlled document directory structure and maintains accurate indices of contents. - Issues, distributes and updates controlled documentation. - Prepares month-end Compliance KPI reports and distributes information to General Manager, Corporate Compliance, etc. - Processes, issues and tracks batch record and other manufacturing documentation. - Propose and/or assist in the review and revision of procedures (e.g., COP, SOP, IOP), reports, specifications and forms. - Prepares, distributes and monitors usage of equipment logbooks, analyst notebooks, etc. - Coordinates correspondence and transference of regulatory documents to FDA, IMB and other regulatory bodies and maintains files to support all documentation systems. - Organizes completed batch production records, prepares and distributes electronic copies to clients. - Provides support to the QA team in preparing for, and during, audits to the HE facility. - Key user of electronic document management system and provides training and support to users. - Reviews, compiles and prepares records for annual performance reviews. - Maintains QA employee training records, summarizes forecasted training requirements and provides quarterly this information to the department heads. - Maintains all Quality System files and archives. - Performs duties in a timely manner and complies with all Company policies and procedures including safety rules and regulations. - Any other tasks which may reasonably be required in accordance with the business needs and keeping with the nature of the role.
ID
2022-9033
Location
IE-Cork
# of Openings
1
Job Family
ADMINISTRATIVE & GENERAL SUPPORT
Job Post Information* : Posted Date 3 months ago(2022/11/3 17:38)
- Achieve and deliver personal sales targets, maximizing profitability of new business. - Prospect for new customers and projects through professional means, including (but not limited to) existing networks, trade shows, introductions and LinkedIn. - Develop, maintain and improve, as applicable, relationships with key contacts and decision makers at all prospective customers to ensure visibility of project opportunities as and when they arise. - Follow-up on key new business enquiries with high potential. - Lead relationships with colleagues in different countries and job functions to ensure enquiries from new or potential customer are responded to accurately and promptly. - Coordinate and/or prepare and issue bids against business opportunities identified with prospective customers, identifying and winning projects that fit Hovione´s available resources and manufacturing capacity - Analyze data, including opportunities with prospective customers, within Hovione´s Customer Relationship Management system for Europe to ensure accurate forecasting - Participate in negotiations of CDAs, Master Service Agreements and Commercial Supply Agreements for allocated accounts in close collaboration with the Senior Director of the area. - Create and monitor targeting maps and plans for the assigned region. - Support the development of competitiveness mitigation strategies, which include (but are not limited to) investigating collaboration agreements, partnering approaches and other potential in-licensing deals. - Identify complex market trends and demands and proposing ideas for new products and services. - Identify new critical opportunities for the existing product and / or services portfolio and linking with the Account Management team as appropriate. - Monitor customer account and market activity and provide concise and insightful analysis on customer dynamics, market developments and competitor activity. - Attend and represent Hovione at key Trade Shows.     Hovione is a proud Equal Opportunity Employer   Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.
ID
2022-9028
Location
US-NJ-East Windsor
# of Openings
1
Job Family
SALES
Job Post Information* : Posted Date 3 weeks ago(2023/1/20 04:46)
Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Rigorously, efficiently and professionally, execute all production/HSE activities, adhering to all applicable procedures and following instructions received from ascending colleagues. - To execute, with supervision, the production/HSE processes. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Be an advocate for safe operating and high quality performance, alerting ascending colleagues to any potential risks and suggesting production/HSE optimizations or improvements. - Develop and accumulate strong production/HSE knowledge. - Demonstrate professionalism in the workplace. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Be responsible for the safe and efficient operation of various equipment (which may vary according to the Production/HSE Area in which the TM are allocated). - Maintain clean and organized facilities. - Attend and participate fully in all meetings and training to which the TM is invited. - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes. - Suggest and participate in improvements in the area in which the TM is assigned. - Ensure that all equipment is checked and calibrated before use. - Ensure the correct identification and use of equipment (labels, plates, logbooks, etc.). - Prepare samples (according to the Area in which the TM is allocated). - Execute production/HSE tasks correctly in Hovione systems (including but not limited to SAP, LIMS, SchedulePro etc.). - Use the Personal Protective Equipment and keep it in good condition. - Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET). - Collaborate in the revision of any area documents as requested (IOPs, others). - Collaborate in internal and external audits / inspections as requested. - Participate, as required, in the induction and training of new Operators across Hovione, Collaborate in the integration of the transferred Operators from other areas. - Follow all annual performance review requirements, including completion of the self-assessment. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2022-9023
Location
US-NJ-East Windsor
# of Openings
1
Job Family
PRODUCTION
Job Post Information* : Posted Date 2 weeks ago(2023/1/27 11:20)
- Perform/manage maintenance on equipment and systems (e.g., mechanical, electrical); - Perform/ manage calibration and metrological activites on intruments; - Evaluate and recommend equipment improvements to increase reliability, capability and yield; - Troubleshoots and diagnoses equipment problems / failures; - Prepares technical reports to document equipment modifications and equipment maintenance procedures; - Ensure all plant equipment and facilities are maintained and its original function is guaranteed and that all departments are equipped to meet their schedules; - Actively contribute to the development of maintenance and calibration reliability for equipment on-site; - Ensure all maintenance work is performed in compliance with GMP directives; - Troubleshoot complex problems related to equipment failure and be able to recommend the best course of action for the effective repair of the same; - Support the technical development of the team to enable them to plan the day to day priorities and site maintenance work; - Participate in definition and assure follow-up of key performance indicators (KPI) for production equipment performance, as well as, for outsourcing services; - Work in a proactive manner to improve safety awareness and metrics; - Participate, control and correct budget activities; - Guarantee the cleaning and orderliness of areas under his responsibility; - Coordinate with other areas the fulfilment of maintenance plans; - Motivate users for the efficient use of utilities; - Guarantee that cGMP rules and procedures are respected within the area, assure that outsource contractors acknowledge internal procedures; - Ensure that SAP data base is updated with new information when necessary; - Manage complex projects/ analysis with significant impact on business.  
ID
2022-9001
Location
PT-Lisbon
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 3 months ago(2022/11/14 12:46)
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Follow the daily priorities in order to accurately and promptly perform the allocated sample analysis, to meet the requirements of the laboratory plan and area KPIs. - To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system. - Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities. - To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures. - To maintain good hygiene and housekeeping within the laboratory. - To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area. - Comply with the high standards in the QC Laboratories. - To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures. - To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories. - Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms. - Undertake any additional tasks to support the laboratory activities as and when required. - Seek out additional information when one feels that the available information is not enough. - Follow all annual performance review requirements, including completion of the self-assessment. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
ID
2022-8995
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 1 week ago(2023/1/31 17:01)
Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.   - Ensures compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) guidelines and regulations. - To ensure that product quality related issues (e.g., recall, quality defects) are notified to the Customers or Health Products Regulatory Authority (as applicable) when product quality issue is of sufficient magnitude to affect the quality/ safety or efficacy of the product. - To promote a Quality Culture and Continuous improvement of standards, through the constant oversight of all applicable Quality guidelines and regulations. - Manages and coordinate the QP objectives and assure that they are in line with the company strategic plan. - Communicates the quality and regulatory requirements to the different areas of the company. - Acts as point of contact and communication of quality issues with the Health Authorities and clients. - Represents Hovione in meetings with Regulatory Authorities and clients. - Provides technical support to internal and external customers on product quality related questions. - Assures that change control procedures consider regulatory marketing authorization implications, especially for critical changes requiring pre-approval, and to inform clients. - Assures and promotes compliance on Health, Safety and Environment in the areas and activities for which is responsible, or in which participates. - Act as decision maker in topics related to legal responsibility of the Qualified Person. - Solve complex problems with full autonomy. - Make quality and timely decisions based on multiple sources of data and regarding a wide array of subjects. - Manage risk and uncertainty; anticipate and address roadblocks in order to prevent deviations to the goals. - Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization. - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). - The following tasks may be delegated, but the QP should have an oversight on them: -Supplier Quality Management - Transparency of the entire supply chain -Involvement in audits and their reports to enable signature of the QP-Declaration Template -Source and specifications of starting and packaging materials -API manufactured according GMP -Excipients manufactured under appropriate GMP -Batch Record Review -Master Batch Records -Validation of all manufacturing and testing processes -Validation Master Plan -Change Control -Rework and Reprocessing -Deviations and investigations -Investigation of complaints and adverse events -Investigation of a quality defect or recall -Access to reference and retention samples -Stability studies and ongoing-stability data -Approval of Quality Agreements -Self-inspection program -Participation in Quality Management Review -Approval of Annual Product Quality Reviews -Involvement in implementation and maintenance of the Pharmaceutical Quality Management System - QP may delegate tasks but can only delegate responsibilities to another QP (registered at the relevant authority). - Specific additional responsibilities may depend on the specific type of products manufactured, as listed below. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. Additional Responsibilities for Drug Substance: - Assure that every batch of active substances (APIs), both human and veterinary use, was manufactured and checked according to the quality requirements of the company, EU Good Manufacturing Practices, local legislation in force, International Guidelines (as applicable) and whenever applicable in accordance with the relevant marketing authorization and/or drug master file. - Accomplishment of the local and international legislation applicable to the manufacture of active substances for use in the pharmaceutical industry (both human and veterinary use). - Coordinate the approval and authorizes the release of the APIs for medicinal products in order to assure that the GMPs and, whenever applicable, the provisions of the marketing authorisation and/or drug master file are applied (for both human and veterinary use). Additional Responsibilities for Drug Product: - Assure that every batch of medicinal products (MPs) or investigational medicinal products (IMPs), both human and veterinary use, was manufactured and checked according to the quality requirements of the company, EU Good Manufacturing Practices (as per EU Directives 2001/83/EC, 2001/82/EC, 2003/94/EC), local legislation in force, International Guidelines (as applicable) and whenever applicable in accordance with the relevant marketing authorization/product specification file. - Accomplishment of the local and international legislation applicable to the manufacture of Investigational Medicinal Products and Medicinal Products (both human and veterinary use). - Coordinates the approval and authorizes the release/certification (as applicable) of the IMPs, MPs and intermediates for medicinal products in order to assure that the GMPs and, whenever applicable, the provisions of the marketing authorisation/product specification file are applied (for both human and veterinary use).
ID
2022-8993
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 3 months ago(2022/11/23 12:19)
•Study, develop, propose and implement new technologies, processes and methodologies related to the relevant scientific discipline to support increased efficiency and excellence, adhering to HSE policies and other operating procedures •Lead the relevant technical aspects of all assigned projects to enable Hovione to meet the established targets •Review, determine and define the course of action in face of technical challenges during any tests and process executions •Communicate and represent Hovione with clients in relation to the scientific discipline in relation to any assigned projects as required •Participate in technology transfers and process validations as required. •Define equipment and resources allocation based upon needs in the area, managing tools (procedures, methods and equipment) under his / her responsibility, throughout their lifecycle, ensuring their correct use and reliability •Assure excellent team and cross-functional communication on any relevant test results and participate in development of subsequent processes accordingly •Guarantee that all assigned tasks distributed to the area are performed within the timeframe defined and according to the scope defined, meeting the predefined KPIs defined for the area. •Take decisions on operations on daily and/or long-term work schedules. •Identify patents and publication opportunities •Promote strategic liaison with specific external providers (industrial, academia, associations and regulators), raising the profile of the Company through technical presentations/papers •Prepare or review Process Documentation, protocols, operating manuals, reports and procedures related to the scientific discipline, maintaining accuracy and timeliness in delivery •Ensure compliance with cGMPs and with HSE policy •Participate in the definition of yearly plans for the area •Assist with audits, investigations and risk assessments as required, following the instruction of Management. •Support the generation / reporting of KPIs for the team. •Develop and accumulate strong scientific expertise, sharing knowledge of new technologies and methodologies within the area. •To provide technical support to other areas of the business, including (but not limited to) the sales team •Provide relevant training to other areas in accordance with established training plans, proposing topics as appropriate •Participate, as required, in the induction and training of new colleagues. •Drive high standards in the area. •Follow all annual performance review requirements, including completion of the self-assessment. •Undertake any additional tasks commensurate with the role as and when required.
ID
2022-8970
Location
PT-Loures
# of Openings
1
Job Family
R&D
Job Post Information* : Posted Date 1 day ago(2023/2/6 16:53)
- Ensure the maintenance, service, repair and troubleshoot of all equipment and installations (mechanical / electrical / instrumentation) on site is performed as per Standard Operating Procedures, Maintenance work instructions or engineering best practices; - Participate in risk assessment of work permits and control of their appropriate execution; - Actively participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D); - Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA); - Ensure the correct completion of all required documentation, paper or system based, associated with own and area work; - Ensure proper tidiness and cleanliness of the maintained equipment and area as well as of his/her working area; - Ensure that area or his/her assign tolls are kept in good shape in what regards to their functionality and cleanliness; - Collaborate in the analysis / investigation of irregularities or CAPAs pertaining to area; - Ability to choose the appropriate methods or tools; - Ability to provide training and support colleagues; - Follow established procedures and processes, with the ability to interpret instructions, drawings and equipment technical documentation; - Resolve non-complex problems related to discipline, with more complex issues being referred to line manager or technical team member; - Adapt to changing site priorities Support other team members in prioritizing work; - Provide guidance and support to colleagues informally; - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes; - Ensure facility activities are carried out in compliance with all GMP, legal and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice; - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice; - Undertake any additional tasks commensurate with the role as and when required.
ID
2022-8965
Location
PT-Loures
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 3 months ago(2022/10/25 09:39)
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Rigorously, accurately, efficiently and professionally manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards / procedures and legal regulations, escalating as appropriate - Propose new methodologies taking into consideration project demands and requirements - Execute project specific analytical tasks and act as a stakeholder liaison - Provide an example of professionalism and support the induction and training of new colleagues within the area - Ensure that all assigned analytical tasks, including (but not limited to) method development, method creation, method transfer, method validation, protocol preparation and report preparation, in any analytical project is well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning - Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period - Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team as appropriate - Reviews work generated by the team as required ensuring all procedures are followed - Creation, investigation and evaluation of CAPAS, incidents and deviations - Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments - Accurately use and maintain all laboratory information systems - To maintain good hygiene and housekeeping within the laboratory - To maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures - Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements - Assist with audits / investigations as required, following the instruction of QC Management - Support the generation / reporting of KPIs for the team, if required - Develop and accumulate strong analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area - Provide relevant training to other areas in accordance with established training plans - Participate, as required, in the induction and training of new colleagues - Drive high standards in the QC Laboratories - Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others - Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data - Work collaboratively in cross-functional teams and understand each departments function and role in delivery of tests and products - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the quality control tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
ID
2022-8928
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 3 weeks ago(2023/1/20 04:12)
  *** This role is an ON-SITE role at our East Windsor, NJ facility:   3rd shift (9:30pm - 6:00am) 8 hr, M-F with pay differential and  bonus.   Performs maintenance on equipment and systems (e.g., mechanical, electrical). Evaluates and recommends equipment improvements to increase reliability, capability and yield. Performs equipment condition analysis (during preventive and unscheduled maintenance). Troubleshoots and diagnoses equipment problems / failures. Prepares technical reports to document equipment modifications and equipment maintenance procedures.   - Participate in the day to day preventative and corrective tasks (mechanical / electrical / instrumentation) in-line with the planned asset lifecycle management instructions - Maintain, service, repair and troubleshoot all equipment and installations (mechanical / electrical / instrumentation) on site as per Standard Operating - Procedures, maintenance work instructions or engineering best practices - Ensure that equipment and infrastructures are maintained within their safe design operating limits, and in a way that avoids danger to personnel or the public - Ensure the correct completion of all required documentation, paper or system based, associated with own work - Participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D) - Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA) - Ensure proper tidiness and cleanliness of the maintained equipment and area as well as his/her working space - Ensure that area or his/her assign tools are kept in good shape in what regards to their functionality and cleanliness - Participate in programs and initiatives required to ensure plant cleanliness - Follow procedures with clear instructions; seeks clarification if they are not clear - Work follows an established pattern, with a requirement to run standard procedures, analysis, reports or tests - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes - Suggest and participate in improvements in the area in which the TM is assigned - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practices - Undertake any additional tasks commensurate with the role as and when required
ID
2022-8901
Location
US-NJ-East Windsor
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 3 months ago(2022/11/16 14:43)
Define and implement quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   This is a 4 cycle shift based role within our In-Process Control Team.   - To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs. - To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system. - Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities. - To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures. - To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area. - To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures. - To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories. - Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms. - Assist with audits as required, following the instruction of QC Management. - Undertake any additional tasks to support the laboratory activities as and when required. - Follow all annual performance review requirements, including completion of the self-assessment. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
ID
2022-8892
Location
IE-Cork
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 5 months ago(2022/9/2 20:56)
Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.            *** On site position for our East Windsor, NJ site               for our 3rd shift 9:30pm - 6:00am ***   - Rigorously, efficiently and professionally, execute all production/HSE activities, adhering to all applicable procedures and following instructions received from ascending colleagues. - To execute, with supervision, the production/HSE processes. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Be an advocate for safe operating and high quality performance, alerting ascending colleagues to any potential risks and suggesting production/HSE optimizations or improvements. - Develop and accumulate strong production/HSE knowledge. - Demonstrate professionalism in the workplace. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Be responsible for the safe and efficient operation of various equipment (which may vary according to the Production/HSE Area in which the TM are allocated). - Maintain clean and organized facilities. - Attend and participate fully in all meetings and training to which the TM is invited. - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes. - Suggest and participate in improvements in the area in which the TM is assigned. - Ensure that all equipment is checked and calibrated before use. - Ensure the correct identification and use of equipment (labels, plates, logbooks, etc.). - Prepare samples (according to the Area in which the TM is allocated). - Execute production/HSE tasks correctly in Hovione systems (including but not limited to SAP, LIMS, SchedulePro etc.). - Use the Personal Protective Equipment and keep it in good condition. - Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET). - Collaborate in the revision of any area documents as requested (IOPs, others). - Collaborate in internal and external audits / inspections as requested. - Participate, as required, in the induction and training of new Operators across Hovione, Collaborate in the integration of the transferred Operators from other areas. - Follow all annual performance review requirements, including completion of the self-assessment. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
ID
2022-8882
Location
US-NJ-East Windsor
# of Openings
1
Job Family
PRODUCTION