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Job Post Information* : Posted Date 2 days ago(2022/12/5 09:38)
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.   - 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) - Assist in the training of more junior members of the maintenance area in their area of expertise - 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
2022-9110
Location
PT-Loures
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 13 hours ago(2022/12/6 17:28)
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
2022-9109
Location
PT-Loures
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 2 weeks ago(2022/11/25 10:22)
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
2022-9085
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 5 days ago(2022/12/2 17:00)
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
2022-9055
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 2 weeks ago(2022/11/21 16:40)
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
2022-9054
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 2 weeks ago(2022/11/24 08:27)
Plan and designs manufacturing facilities and related structures. Determines facility specifications, including analysis and evaluation of location, material resources and structural design. Resolves technical problems and recommends installation improvements to meet process requirements.   - Assist in the selection the most adequate engineering solutions complying with the user requirements and also promoting wellbeing of the users, ergonomics and productivity during the use of the installation  - Support the design and implementation of engineering solutions on the specific areas of engineering projects in order to achieve the company established objectives through successful project conclusion  - Assist the procurement phase of specific components from bids to goods reception confirmation  - Contribute to the preparation or revision of technical documentation of the Engineering projects, for the conceptual, basic and detailed design phases  - Support the completion of project documents packages for a competitive tender process  - Gather or assist in data provision for the preparation of project budgets and timelines  - Support the preparation of Engineering Standards comprising best available and cost-effective solutions, based on proven solutions  - Assist in the construction, installation, commissioning and qualification of assigned projects, within is area of responsibility  - Coordinate and verify external technical documents, guaranteeing alignment with the internal documents  - Execute all assigned tasks, delivering on time, safely, efficiently, reliably and in a cost-effective manner  - Assist Engineering and project management to resolve project issues, ensuring the delivery/completion of the project work  - Capture user feedback and lessons learned for future projects  - Propose improvements (procedures, organizational, new technologies, capex, productivity) in Engineering as appropriate  - Make quality and timely decisions within the Design Engineering tasks under her / his responsibility  - Execute professional activities in compliance with GMP, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)  - Gather relevant data to inform the decision makers regarding complex issues  - Updates the Area Director of relevant occurrences and trends that may have a significant impact on the business  - 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
2022-9048
Location
PT-Loures
# of Openings
1
Job Family
ENGINEERING & MAINTENANCE
Job Post Information* : Posted Date 4 weeks 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 weeks 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 weeks 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 2 weeks ago(2022/11/21 17:27)
- Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured; - Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports; - Prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary; - Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site audits; - Periodic follow-up of ongoing deviations and Change Controls (PdAs) to assure timely closure of deviations and approval of PdAs, as appropriate; - Prepares SOPs, department IOPs, quality related reports and change control documents (PdAs) as required and appropriate; - Review process master documentation, revision of executed batch documentation and product specifications as required and appropriate; - Review regulatory documentation and co-ordination of site documentation to support regulatory requirements; - Authorize the usage of production equipment/utilities when qualification required.
ID
2022-9029
Location
PT-Loures
# of Openings
1
Job Post Information* : Posted Date 1 month ago(2022/11/3 15:50)
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 projects in the allocated area and escalate complex issues to more senior colleagues or managers. It is recognized that the level of support required will increase when projects that are more complex are assigned. Project assignment will always be based on business need, however, preferentially, projects assigned will have a medium to high degree of complexity including - a medium to high cumulative sales / project cost value - a medium to high project control level - up to a high customer segmentation level - 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. - Participate in 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. - Develop knowledge related to PM methodologies, tools and techniques. - Master project management processes and tools. - Manage complex projects/ analysis with significant impact on business. - Make quality and timely decisions based on multiple sources of data. - Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals. - Follow 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
2022-9022
Location
PT-Loures
# of Openings
1
Job Family
GENERAL MANAGEMENT
Job Post Information* : Posted Date 2 weeks ago(2022/11/21 17:34)
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.   - Apply and develop knowledge of Quality Control and participate in area processes, procedures and projects with the guidance of more senior colleagues - 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 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 (with support from senior colleagues) 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 reporting of KPIs for the team, if required - Develop and accumulate strong analytical chemistry expertise - Maintain 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 - Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner - 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. - Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
ID
2022-9015
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 5 days ago(2022/12/2 16:54)
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.   - Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready” - Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities - Act as a catalyst for change and improvement in performance/quality - Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR - Provide an example of professionalism and support the induction and training of new colleagues within the area - Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured - Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports - To prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary. - Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site audits - Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate - To close open deviations and propose CAPAs based on the outcome of periodic follow-ups - Prepares SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate - Approves IOPs, process master documentation and product specifications as required and appropriate. - Ensures that SOPs and IOPs are up to date, compliant and supports efficient production - Review regulatory documentation and co-ordination of site documentation to support regulatory requirements - Authorize the usage of production equipment/utilities when qualification required - Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required - Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate - To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates - To maintain a regular presence on manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required - To approve Validation Master Plans, Process Validation Protocols and reports as required - Accurately use and maintain all information systems - Support the generation / reporting of KPIs for the team. - Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area - Co-ordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes - To provide relevant training to new colleagues, and to the other areas in applicable cGMP, internal procedures and quality systems in accordance with established training plans - 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 - 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 Assurance 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.
ID
2022-9006
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 3 weeks 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 2 weeks ago(2022/11/21 16:42)
- 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
2022-8984
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 4 weeks ago(2022/11/10 16:46)
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.   - 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
2022-8983
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 1 week ago(2022/11/29 15:58)
Provides secretarial / administrative support to employees or groups in the organization. Receives, screens and directs incoming calls, visitors, mail and email. Maintains files, records, calendars and diaries. May arrange business travel, coordinate meeting arrangements and / or track expenses. Uses standard and/or advanced business software applications (e.g Microsoft Office, SAP, documentation control, analytical software) to prepare correspondence, presentations, agenda, minutes, etc. Acts as key user for area specific tools. Prepares technical reports, document or indicators based on specialized documents. Updates planning and communications in support of decisions made.   - Research a wide variety of information requests independently - Receive, classify, reconcile, interpret, consolidate and/or summarize documents and information using the tools and systems required for these purposes Maintain records and balance information for control purposes - Fill documents and prepare administrative documents within prescribed guidelines - Compose routine letters and memoranda - Route or answer routine correspondence, composing letters and memoranda - Receive and refer visitors and telephone calls - Open and distribute mail - Make meeting and travel arrangements - Maintain schedules and administer systems or arrangements for activities such as purchase, receipt, dispatch and delivery of goods and / or services - Deal with external sources such as customers and / suppliers in order to resolve non-routine queries and problems - Work follows an established pattern, with a requirement to run standard procedures, analysis, reports or tests - Able to prioritize own work - 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 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 - 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
2022-8974
Location
PT-Loures
# of Openings
1
Job Family
ADMINISTRATIVE & GENERAL SUPPORT
Job Post Information* : Posted Date 7 days ago(2022/11/30 15:05)
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.   - Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready” - Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities - Act as a catalyst for change and improvement in performance/quality - Provide an example of professionalism and leads the induction and training of new colleagues within the area - Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR - Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured - Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports - To authorize the release for sale of finished products (applicable to site without QP) - Prepare for and support internal and external site audits and inspections, leading regular reviews and periodically following-up action plans as necessary - Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits, taking a lead on the most complex situations - Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate - Close open deviations and propose CAPAs based on the outcome of periodic follow-ups - Prepare SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate - Approve IOPs, process master documentation and product specifications as required and appropriate. - Ensure that SOPs and IOPs are up to date, compliant and supports efficient production - Review regulatory documentation and co-ordination of site documentation to support regulatory requirements - Authorize the usage of production equipment/utilities when qualification required - Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required - Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate - Assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates - Maintain a regular presence on manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required. - To approve Validation Master Plans, Process Validation Protocols and reports - Accurately use and maintain all information systems - Support the generation / reporting of KPIs for the team - Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area - Coordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes. - Lead the development and sign-off of training materials and provide relevant training to new colleagues, and to the other areas in applicable cGMP, internal procedures and quality systems in accordance with established training plans - Proactively lead the provision of support to less experienced colleagues in the undertaking of their duties - 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, including those that have the potential to mitigate unnecessary complexity - Master Quality Assurance processes and tools - Manage complex projects/ analysis with significant impact on business - Make quality and timely decisions based on multiple sources of data - Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals - 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.
ID
2022-8973
Location
PT-Loures
# of Openings
1
Job Family
QUALITY
Job Post Information* : Posted Date 2 weeks ago(2022/11/23 10:47)
The Warehouse Specialist will be responsible to ensure all warehouse activities are carried out correctly and in efficient way following the cGMP/GDP, HSE rules and internal procedures. - Execute professional activities in compliance with GMP, GDP 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); - Verify that the quality policy is followed by the warehouse teams; - Maintain the departmental IOPs updated and their execution within the area; - Verify that stocks are under proper storage and control, conducting controls over goods; - Verify that required materials quantities for production and internal clients are provided as per schedule; - Implement new warehouse processes and methodologies according to guidelines; - Analyze warehouse and logistics data, producing reports relevant for area; - Contribute with proposals for the increase productivity and compliance; - Ability to gather data that is relevant for the decision making process in the area - Collaborate in the training of warehouse teams, proposing contents and delivering training sessions when required; - Follow customer and authorities audits and inspections and implement needed changes as requested.
ID
2022-8972
Location
PT-Loures
# of Openings
1
Job Family
SUPPLY CHAIN, LOGISTICS & PROCUREMENT
Job Post Information* : Posted Date 19 hours ago(2022/12/6 11:04)
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.   - Liaise with the area Team Leads, Supervisors, Process Engineers and Managers to identify areas of development that require training or new processes that will require the operators to acquire new skills or competencies - Ensure all documentation under direct responsibility is correctly completed and maintained. - Review and propose content to be delivered and work with L&D to choose the best delivery option - Deliver training to new and existing operators in order to ensure that all are prepared and are capable to execute their assigned job. This will include the onboarding training of new employees. - Ensure the training records are kept up to date and accurate - Able to react to changing priorities, undertaking any additional tasks commensurate with the role as and when required - 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. - Suggest and participate in improvements in the area in which the TM is assigned. - Act as a subject matter expert to less experienced colleagues. - 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 an advocate for safe operating and high quality performance, identifying and mitigating any potential risks - Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro, and XNET) - Provide continuous input and feedback regarding the performance of the team, setting a role model reference regarding both soft and technical skills. - 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. Be able to provide oversight/statistics on current operational training status.
ID
2022-8971
Location
PT-Loures
# of Openings
1
Job Family
PRODUCTION