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- Perform maintenance on equipment and systems (e.g., mechanical, electrical); - Evaluate and recommends equipment improvements to increase reliability, capability and yield; - Perform equipment condition analysis (during preventive and unscheduled maintenance); - Prepare 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; - 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; - 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); - Undertake any additional tasks commensurate with the role as and when required.

- Study, review, optimize and apply HSE Process safety procedures, proposing improvements as appropriate; - Communicate and engage with internal and external stakeholders, advising and liaising as appropriate; - Provide subject matter support, working to enhance site HSE capabilities and performance in a responsive and professional manner; - Coordinate, implement, support and maintain an effective management HSE Process Safety Management System at the site to assure and promote site compliance with all applicable legislation, policies and operating procedures; - Identify and propose improvements to the HSE Management System in order to maintain compliance with legal requirements, best practice and Hovione strategic plans; - Evaluate the Safety and Environmental Risks associated with New Process Introductions as well as modifications to existing Processes to determine the necessary controls required to ensure safety; - Conduct technical assessments of new equipment and facilities utilizing recognised formal risk assessment methodologies as appropriate to the assessment e.g. Hazop, PHA, LoPA, etc; - Identify and assess Major Accident Scenarios as required under the Comah regulations and in line with company procedures; - Maintain and update Hazard Area Classifications; - Conduct Chemical Risk assessments; - Verify and monitor site compliance with HSE Process Safety requirements and procedures, producing and presenting reports; - Maintain accurate statistical data and records related to HSE Process Safety activities; - Support and provide relevant training in accordance with established training plans, proposing topics as appropriate and updating plans according to Hovione needs; - Provide technical support to the operating and manufacturing operations to help resolve issues and determine best practice relating to site safety and environmental performance; - Establish procedures and practices to maximise the effectiveness of the site emergency preparedness response; - Participate and lead as required, investigations into HSE events to identify appropriate corrective actions; - Plan, participate and support internal audit programmes to routinely verify the continuing effectiveness of the site HSE Management System; - 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).

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.

Delivers excellence in end-to-end process improvement practices, methodologies and behaviours to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviours and enable alignment of priorities across areas. Supports the continuous improvement cycle aiming at the sustainable increase of unitary output (effective throughput per resource unit used). Responsible for developing, deploying and maintaining the most adequate methodologies and workflows, looking at maximization of workforce efficiency and adoption of the appropriate behaviours to enable engagement; as well as for deriving metrics to measure plant and equipment capacity to support identification of equipment and process flow bottlenecks, contributing to improved layouts whilst assuring compliance with established guidelines.   - Implement productivity actions and define priorities within own work to achieve the proposed goals (efficiency, efficacy and cost consistency) - Drive, manage and train the teams that will take part on Continuous Improvement Initiatives, problem solving and risk assessment groups - Coach operational teams in their daily communication meetings, ensuring that defined methods are properly used in all areas - Support the development of Operational Excellence Training Program and run training sessions - Update the productivity indicators of the plant - Support a Continuous Improvement process in the plant that is visible for all, through indicators, working methods, visual management, etc. - Ensure the constant reduction of the time and costs required in all activities in Manufacturing - Ensure that all operational staff are trained according to Operational Excellence training procedures in place - 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 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.

- 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 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

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.     - Coordinate and supervise activities within the area and prioritize activities in case of conflict between simultaneous production lines / projects to ensure that the deliverables of each project are dealt in the team within the timeframes defined, with the appropriate quality and according to cGMP and that an outstanding service is provided to all customers (internal and external) - Ensure that all TMs of the team have suitable training and qualifications to the work they perform - Participate in client meetings, external and internal audits and Product/Project teams representing own area specialization - Review and approve analytical test methods to be executed in own laboratory - Review and approve reports prepared in own laboratory - Check and approve raw material, intermediate and final product batches, stability samples, In Process and COL samples and/or all samples sent for QC from own laboratory - Manage all defined stability programs in terms of protocl preparation, inventory management, analytical testing execution and data release - Ensure all safety and quality events are investigated and root cause determined with CAPA’s identified and executed - Coordinate the timely execution of the preventive maintenance program and execution of corrective maintenance. - Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences - 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 area strategic objectives - Monitor Communication´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures - 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 - 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.

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.

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.

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

- 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;

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.

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.

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).

•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.

- 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.

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.

- Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented. - Develop & Maintain a competences framework covering the areas of Health Safety & Sustainability (HSS). - Establish and maintain HSE Academy curricula appropriate to risks and regulatory requirements and aligned with Global and Site needs. - Working with stakeholders, establish and lead a governance process for the development of transversal training content to maximize efficiency and effectiveness and support as necessary the development of site/function specific content as needed. - Working with stakeholders establish and lead a governance process for the approval of trainers for the HSE Academy ensuring trainers have the appropriate experience, knowledge, and competency to deliver assigned training. - Develop and review as appropriate learning support materials for trainers to ensure transversal training is delivered in a manner which is consistent across the company. - Work the Global Human Resources and Learning & Development to ensure the effective roll out and operation of the Hovione Learning Academy. - Monitor Performance KPIs for L&D within HSE and generate training status reports for management. - Develop and propose for approval an annual activity plan and related budget for the Area under responsibility in line with the unit's strategy, to align activities with the department strategic objectives - Monitor the approved HSE L&D budget, identifying any deviations against plan and taking corrective measures as necessary. - Promote the introduction of innovative Learning & Development methodologies or technologies during the revision and implementation of the training contents. - Promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures, and training. - Working with stakeholders and in alignment with Global Communications, develop and lead the implementation of a communication plan in support of company objectives in the areas of Health, Safety & Sustainability. - Support the work Global Health Safety & Sustainability.

Performs engineering work in operations, production, construction or maintenance environments. Responsibilities are within the Engineering Family as a generalist or in a combination of disciplines. Understands the roles and workflows of the Engineering and Maintenance functions.   - Manage and support 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. - Translate business cascade goals into departmental and individual goals and clearly communicate goals to team. - Providing leadership and direction to colleagues within the area to ensure that goals, targets and expectations are communicated clearly. - 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. - Appraise team performance, coaching team members to elevate their performance through development plans and address poor performance through improvement plans together with HR business partner. - Select the best performers for career advancement in accordance with the organization needs - Define and review the list of the area technical competencies and establish training plans to develop such competencies. - Responsible for generating annual master plans for the area including costs and resource requirements and clearly defining on how success will be measured for the area responsible; - Ensure execution of engineering or maintenance activities within area of responsibility using excellence asset life cycle approach. - Manage outsourced engineering, maintenance or facility contracts and resources to meet site requirements. - Constantly seek for productivity in the group, questioning practices and measuring activity time to enable simplification and productivity gains - Ensure equipment and processes are engineered, maintained and operated within all local, national, business codes and regulations; - Create the conditions for own team to meet all predefined KPI’s for area. - Monitor the area 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 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.

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.

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.   - Use as standard for own work high-quality levels and a mindset of continuous improvement - Advise Team Members on Quality or Regulatory systems and Tools and provide support in the what are the best courses of action - Provide support in the preparation of new procedures and/or policies according to the requirements applicable to the company business and strategy and propose changes to the existing procedures as applicable - Provide support in the preparation of Quality and/or Regulatory Systems and Tools related documentation and training - Provide support to audits/inspections (Internal and of Health Authorities) Participate in other Corporate key activities, such as 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, analytical computerized systems fillings, customer support, etc.) - Apply and develop knowledge, on applicable systems and participate in area processes, procedures and projects with the guidance of more senior colleagues - 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. - 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 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).