For an international Global Specialty Pharmaceutical Company with state-of-the-art biopharmaceutical products in oncology, nephrology and immunology, I am currently looking for an Associate Director / QP to set up their QP Department in the Netherlands.
You will support the maintenance of the established MIA and perform batch release and certification of commercial products. You will also manage regulatory inspections and support continuous development of the QMS (GMP/GDP).
- Maintain GMP license and ensure that the provisions of the MIA is observed
- Ensure that the QMS is effectively established and maintained to support the active licenses (WDA, MIA and CDL)
- Perform Internal/Extern audtis
- QA Oversight acitivities of CMO's
- Ensure Global QA Plan for commercial GMP/GDP activities
- Batch certification and release of commercial products
- QP review and evaluation
- Act as Back-up RP
- 3-5 years of working experience as QP in an European Country
- Experience in release of commercial products, preferably biotech/sterile products
- Extensive knowledge of GMDP
- Fluent in English, Dutch is an advantage
- Good communication skills, verbal and written
My client is offering a permanent contract with a highly competitive salary and interesting secondary benefits.