Quality Manager with GMP Experience (m/f)

REFERENZNUMMER:

269807/1

IHRE AUFGABEN:

-Define services and service levels in the area of quality operations
-Establish written agreements to ensure that pharmaceutical products are manufactured by contractors and provided to patients in accordance with pertaining pharmaceutical rules, e.g., AMWHV, AMG - Review Quality Assurance Agreements currently in place at PMD.
-Create and manage list of agreements required for the new LE
-Work with our clients contacts to determine concerned services and processes, and monitor any changes that may evolve while preparing for LEA
-Prepare initial document drafts for negotiation with internal and external partners, based on existing PMD service agreements as applicable
-Write, manage, and maintain quality agreements in accordance with our clients procedures and legal expectations
-Contact partners and start negotiations involving concerned internal departments (e.g., Quality Operations, Production, EHS, Legal, Purchasing, etc. as applicable)
-Discuss and verify internal expectations against contractor's service levels. Follow up with partners on contract content, manage resolution of conflicting expectations, adjust in agreement with our clients Quality standards, in close collaboration with our clients Quality Operations and Legal
-Complete all agreements according to agreed timelines
-Support vendor qualification program by establishing appropriate contracts in accordance with §11, AMWHV

IHRE QUALIFIKATIONEN:

-Approbation as a pharmacist
-Profound knowledge of GMP
-Profound knowledge of Quality Management
-Profound knowledge of implementation of new standards

WEITERE QUALIFIKATIONEN:

Pharmacist, Quality manager