Lyon, Auvergne-Rhône-Alpes, France
- Define processes and strategies for products and processes validations within BIAH in order to ensure inter-site consistency and alignment regarding the Right Level of Quality - Be the link between BI validation policies and their implementation in BIAH - Ensure the role of Divisional MSO for Process validation and Cleaning Validation - Diagnose the site validation strategy (sVMP) and contribute to the definition of corrective, preventive and rationalization actions - Manage working groups by structuring and piloting the search for solutions or optimization in the context of the global strategy of sites validations - Implement and ensure compliance of Global Quality documentation for the products and processes validation - Set up a network around the validation process to give a common vision - Support sites to identify and justify the resources needed to implement the validation strategy - Provide support, expertise, methodology and training on validations in order to control compliance within the network and for all AH sites - Pilot the implementation of the strategy and ensure the associated traceability measured through relevant indicators - Support, negotiate and defend BIAH's regulatory positions with the authorities or during corporate audits
Missions: • Ensure deployment and ensure compliance with strategy and quality documentation for facilities, utilities and equipment identified in the ACE Strategic Investment Project (Agile Center of Expertise: New R&D Building + Transfer of R&D and Industrialization activities from Lyon Gerland to Saint-Priest. • Be responsible and leader of the quality part of the ACE project, namely: - Ensure that the project complies with current pharmaceutical regulations and the internal rules. - Define the overall strategy for qualification and validation of the project. - Identify, justify and recruit QA resources required for project. - Coordinate and manage the Quality team – 8 QAPM + 5 Qualification technicians (alignment of approaches and methodologies, definition of milestones, progress of tasks ...). - Drafting or being the guarantor of the drafting, verification, approval and distribution of the Validation Master Plans and Reports, Criticality Analysis (CA) and Risk Analysis (RA) - Write the request for modification of premises sent to Authorities. - Participate in the evaluation of suppliers and providers consulted in the project. - Write or audit qualification protocols and reports (DQ, IQ, OQ, PQ) + Tests participation - Plan, coordinate and supervise the qualification steps (DQ, IQ, OQ, PQ) internally with engineering and user project managers; And externally with suppliers and service providers. - Review and verify project functional and technical documents with quality impact - Supervise the quality points of the ACE strategic project by managing, facilitating or participating in Quality Assurance (QAPT) project team meetings. - Participate in various technical meetings (internal and external) and steering committee meetings. - Build and Manage the Quality Projet progress indicators - Support or collaborate with R&D QA for the management and implementation of validations strategy
Missions: ▪ Define, deploy & maintain the Quality Policy across MERIAL sites through the implementation and monitoring of Quality Systems, based upon SANOFI, MERIAL & pharmaceutical regulatory requirements ▪ Implement and maintain QA documentation relative to the management of investment projects. ▪ Harmonize the qualifications/validations approaches for all investment projects on MERIAL sites in compliance with GxP. ▪ Streamline the qualification/validation strategies between sites and between entities (Industrial Operations (I&O) entity and Research & Development (R&D) entity). ▪ Ensure that critical investment projects are compliant to QA requirements (Policy, directives, standards…) and are aligned with Corporate QA strategy. ▪ Provide expertise, training, support and tools for investment project management in terms of QA compliance. ▪ Audit critical investment projects and sites Qualification/Validation policy according to MERIAL and SANOFI strategies.
Missions: ▪ Define, prepare and maintain Global Quality policies and directives that allow sites to implement the exact level of quality ▪ Ensure the implementation of policies and directives by the sites (site audits, assessment of the compliance level) ▪ Follow the regulatory texts governing the pharmaceutical industry and GMP (Pharmacopoeia, etc..) to adapt the system to these quality requirements ▪ Build and implement a program of MERIAL sites and suppliers and subcontractors audits then follow the action plans ▪ Ensure the consideration of quality requirements in strategic projects and identify the quality critical points in the projects and monitor them (e.g., due diligence, transfer) ▪ Design, develop, improve and deploy the Global QA activities at international level ▪ Establish the MERIAL position in view of regulatory changes or requirements ▪ Provide expertise (like validation policy, control of biological risks related to raw materials of animal origin) and methodological support (risk analysis, change control ...) to the QA manager in their missions
Missions: ▪ Insure the development of QA system of the Industrialization (IDBio) department ▪ Ensure that the IDBio department has a homogeneous and technical documentation in accordance with the rules of MERIAL documentary architecture ▪ Ensure the correcting and follow-up of manufacturing master file batches ▪ Manage internal audits to monitor the level of quality improvement ▪ Guarantee that processes and techniques are validated in accordance with the registration records. ▪ Manage the follow-up of qualifications and validation of new equipment or equipment modification projects ▪ Manage the deviations ▪ Represent QA in projects group (R&D to IDBio and IDBio to Production) to ensure compliance with procedures and guidelines and quality of biological processes transfers to R&D to Manufacturing