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  • 1 week ago

jobs description

Pharmélis, a recruitment consultancy and training organisation specialising in executive, expert and managerial positions, and a partner to companies in the healthcare sector (pharmaceuticals, cosmetics, medical devices, biotechnology, etc.) for over 18 years, is helping its client, an international pharmaceutical laboratory, to recruit a QA Manager for the France subsidiary.

Reporting to the Head of QA Europe, your tasks are as follows:
• SME for GMP and GDP in France,
• Leads and participates in GMP/GDP audits in Europe – responsibility for all vendors in Europe,
• Reviews and approves Deviations, CAPAs, QMS Review, SOPs, PQCs contracts,
• Host of GMP/GDP QMS review,
• Manages process for ensuring Responsible Person oversight for issues among RPs,
• Owner of supplier qualification process for supply chain of commercial products,
• Support for due diligence for new in-licensed products for commercial products supply chain,
• PV responsibilities in accordance with local... requirements.

• You hold a Doctor of Pharmacy degree.
• You have at least 5 years' experience working to high GxP standards.
• You have experience as an international auditor.
• You have experience of writing and delivering training materials for topics such as lessons learned, procedural documents, changes to the regulations and laws.
• You are able to adapt to new IT systems and processes quickly with appropriate training.
• You have experience in managing aspects of a Quality Management System and/or electronic training system
Paris France


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