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Supply QA Officer
il y a 2 semaines
Job description As a Supply QA Officer, you will assist the Supply QA team in establishing, implementing, maintaining, and continuously improving, an effective Level of Quality linked to the supply chain activities, including purchasing/procurement and warehouses activities, on the company site by:
- Assisting in drawing up, review and approval of procedures and instructions related to these activities
- Being one of the QA representatives for those activities and departments on the company site in case of alignment and level of quality related issues
- Treating alignment and level of quality related issues and follow up on the related corrective and preventive actions (via deviations handling, follow up of change control, initiation of investigation, follow up of complaints)
- Performing continuous GAP analysis between new expectations and Quality Management System documentation and between the company documentation and actual practice (update Risk Register regularly)
- Performing supplier audits in order to evaluate their level of compliance with Quality Agreements, contract agreements, the company Corporate Guidelines, and governmental regulations
- Ensuring that suppliers define corrective action plan, where needed
- Ensuring follow up of the implementation of corrective action plans
- Ensure the cold chain and controlled temperature process in order to maintain/ improve the GDP practice.
- In response to business requirements, identify, treat and communicate to QA and BTO management the possible issues of non-cGMP/21 CFR 820 compliance within Quality Management System and provide cGMP and QA expertise, interpretation and direction in order to create a framework of operational excellence enabling implementation of continuous improvement (e.g.: technical changes).
- Be one of the QA representatives in case of external audits regarding specific domain of knowledge (Master Data, purchasing, vendors management, warehouse, ... )
- Train the company personnel regarding cGMP/21 CR 820 and Level of Quality requirements related to supply chain, purchasing, warehouse, operations, cold chain and SAP aspects.
- As SAP User, provide cGMP and QA expertise, interpretation and direction on SAP system enabling implementation of continuous improvement regarding specific domain of knowledge (Master Data, purchasing, vendors management)
- Scientific Master's Degree
- Fluent in French & English
- Commitment to quality, reliability and discretion
- Problem solving (describe the level of "self-starting" thinking required in the for recognizing, analyzing and solving problems)
- Knowledge of problem-solving tools (FMEA, Keppner Trigoe, ...)
