QA Manager for GMP and GDP compliance
Gloor & Lang
- Basel
- Unbefristet
- Vollzeit
- Provides Quality oversight of external GDP operations.
- Leads Supplier and Service provider qualification activities, including audits and management of Technical Quality Agreements with Suppliers and Service Providers
- Support Batch Record review, release preparation and batch disposition of commercial APIs, bulk drug product, and finished products manufactured by contract manufacturers
- Provide Quality oversight of external GDP operations
- lead QMS activities, Complaints, Deviations, Change Control, Audits, Self-Inspections and Training
- Support Batch Record review, release preparation and batch disposition of APIs, bulk drug product, and finished products manufactured by contract manufacturers on behalf of Basilea.
- Monitor performance metrics, provide regular updates to management on assigned project progress, and escalate challenges as needed.
- Execute and support external and internal audits (GDP/GMP).
- Support Health Authority inspection and customer audits preparation and management.
- B.Sc, M.Sc. Life Sciences
- Excellent knowledge in GMP and GDP regulations
You act as a quality influencer throughout all steps in the multi-site supply network and are talented to build trustful and effective relationships, knowing your problem solving attitude and clear QA strategy vision will be a key success factor. Your optimistic and enthusiastic attitude will be an asset in the familiar QA setting.