Description
We are looking for a
Contract Manufacturing Quality Manager (m/f)
Reference: -en
Start: asap
Duration: 7 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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 to 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 and operations 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 per the Quality Agreement
- Perform quality risk assessments, develop mitigation plan and follow-up on implementation
Your qualifications
- Chemist or Pharmacist (must)
- Profound xperience in pharmaceutical in manufacturing, quality assurance or quality control
- Project experience in a quality role
- Experience in operating quality systems in pharmaceutical operations
- Demonstrated proficiency in interpretations of cGMP regulations, both US and international
- Proficiency in German and English
Skills:
- Quality manager