Spécialiste AQ - Site Exploitant, France (CDD 8 mois)
Core
Maintaining and improving the quality system for pharmaceuticals, medical devices, cosmetics, and aesthetic products at the operating site.
Role type
Quality Assurance Specialist (Site Operating)
Builds
Quality management system compliance and operational quality processes for AbbVie France
Domain
Pharmaceutical industry / Quality Assurance
Required skills
Quality management system knowledge, regulated environment project management, Change Control management, Serialization alert management, Product Quality Review (PQR) coordination, Promotional Information Charter management, Documentation review and alignment, Internal training delivery, Inspection and audit support
Preferred skills
Production site experience
Technologies
Office tools (Excel, Word, PowerPoint), IT systems associated with quality management
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 counterfeiting, Participate in shortage management and maintain Shortage Management Plans, Coordinate local Product Quality Reviews (PQR), Contribute to the management of the Promotional Information Charter reference, 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