Global Quality Consultant CMO (m/f)

REFERENZNUMMER:

294546/11

IHRE AUFGABEN:

-Prepare quality agreements and corresponding product specific requirements (PSRs)
-Negotiate and maintain quality agreements with selected CMOs and ensure the requirements of the quality agreement are fulfilled (in collaboration with other quality functions)
-Provide technical expertise and guidance for the external quality small molecules organization by supporting or managing deviations and investigations, changes, specifications and regulatory submissions
-Participate in due diligence visits to assess CMO quality systems for development and processing of investigational medicinal products
-Build strong relationships with both internal operation units and external CMOs
-Collaborate with internal departments to achieve goals through aligned processes
-Participate in the design, implementation and maintenance of quality systems for small molecules for execution of the above function
-Provide equipment/facility qualification and process validation support to small molecule programs
-Implement appropriate systems as necessary
-Review and approve validation protocols for the quality agreement
-Perform quality risk assessments, develop mitigation plans and follow-up on implementation

IHRE QUALIFIKATIONEN:

-Chemist or Pharmacist
-Profound experience in pharmaceutical manufacturing, quality assurance or quality control
-Project experience in a quality role
-Experience in operating quality systems in pharmaceutical operations
-Demonstrated proficiency in the interpretation of cGMP regulations, both US and international
-Proficiency in English

WEITERE QUALIFIKATIONEN:

Quality manager