Description
We are looking for a
Global Quality Consultant CMO (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in the 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 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
Your qualifications
- 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
Skills:
- Quality manager
Keywords: Qualitätsmanager