Senior Quality Officer/Specialist
+32 496 49 18 21
Description de l'emploi
- Release product in accordance with approved specifications and procedures.
- Monitor contractor compliance via GxP documentation review and on-site visits/audits.
- Implement methods and procedures for inspecting, testing, and evaluating the precision and
- accuracy of products and production equipment.
- Compile data and write summaries for periodic product reviews, investigations, complaints, and
- Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter
- Expert review.
- Interact with multi-functional internal and external project teams to ensure compliance.
- Respond to technical and quality issues and handle schedule and/or process-related conflicts.
- Demonstrate understanding of applicable US and global regulations related to manufacture of
- medicinal products (small molecules and biologics).
- Monitor contractor performance to established Key Performance Indicators (KPI) and report
- adverse trends.
- Provide guidance to less experienced staff, as applicable.
- Bachelor’s or Master degree and 3-5 years of experience in a cGxP or other regulated environment, to include +3 years in a Quality role
- Excellent communication and organizational skills