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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.
Role Description 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).
Responsibilities
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
Requirements
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
Other Information My client is offering a permanent contract with a highly competitive salary and interesting secondary benefits.
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