Spécialiste AQ - Site Exploitant, France (CDD 8 mois)
Core
Maintaining and improving the quality system for pharmaceuticals, medical devices, cosmetics, and aesthetic products at an operating site.
Role type
Quality Assurance Specialist (Site Operating)
Builds
Quality management systems and compliance processes for pharmaceutical and medical device operations
Domain
Pharmaceutical industry / Quality Assurance
Required skills
Quality management systems knowledge, project management, regulated environment experience, Change Control management, serialization alert management, shortage management, Product Quality Reviews (PQR) coordination, promotional information charter management, group and subsidiary documentation alignment, internal training delivery, regulatory inspection support
Preferred skills
Production site experience
Technologies
Excel, Word, PowerPoint
Responsibilities
Manage the quality system under the QA manager's responsibility, participate in continuous improvement and non-conformance management, manage Change Controls at the operating site level, manage serialization alerts to combat drug falsification, participate in shortage management and maintain shortage management plans, coordinate local Product Quality Reviews (PQR), contribute to the management of the Promotional Information Charter, review and align group and subsidiary quality documentation, participate in internal training on quality expertise areas, provide support during health authority inspections and corporate audits
Seniority
Mid-level, hands-on IC
