Recommends, implements and maintains a quality management system tailored to the company's needs and the regulatory status of the site's activities.
Implements this system to meet applicable regulatory requirements for the site (GLP, GCP, GMP, GDP, ISO and other relevant standards).
Defines and implements quality actions appropriate to the site's various activities.
Sets standards for the quality training program to ensure implementation of the quality strategy and policies.
On delegation from the Responsible Pharmacist, accepts raw materials, packaging and commercial products (cosmetics, pharmaceutical intermediates, medical devices, medicines).
Ensures site readiness for regulatory inspections and customer audits.
Manages a process
and risk-based approach to auditing the site, its subcontractors and its suppliers.
Ensures that the product batch record review process is appropriate.
Defines and manages the archiving and records management strategy.
Releases technical batches and investigational batches of cosmetics and medical devices.
Approves the GxP qualification/validation plan for facilities, equipment and systems.

Holder of a Doctorate in Pharmacy and a Master's degree in Quality Assurance or an equivalent qualification
At least 7 years' experience managing internal and external audits
Proficiency in GLP, GMP, GCP and GDP standards

Quality Assurance Manager – Fixed-term contract

Key skills