Global Quality Specialist
- Freelance
- Pharmaceutical
For one of our clients, a top 5 pharmaceutical global player, we need to find a Consultant QA for a period of minimum 12 months.
Vacancy information
- Drug substance and drug product batch disposition (release/reject decision),
- Product certification and release by the EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors
- Assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections
Principal Objective of the Position: Provides support to Qualified Person (QP) for R&D supplies shipped through EU Central Warehouse (EUWH) and provides QA support to CSO R&D Logistics.
Key Responsibilities and Major Duties:
- Compiles Qualified Person batch release dossiers
- Supports Packaging & Labeling activities performed at EUWH
- Provides Quality Assurance support in the Use Date Extension process
- Provides Quality Assurance support (GMP/GDP guidance and training) for CSO R&D Logistics
...
Requirements information
Wanted : Experience in QA, specific formation is foreseen by the client.