Modis is looking on behalf of a client for an experienced QA Manager involved in projects of process characterization.
• Ensure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to procedures, and in compliance with regulatory guidance
• Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation
• Leading the process validation teams including communication with customers
• Support R&D teams during the process design phase
• Preparation of the validation protocols and reports for the studies performed at manufacturing scale
• Assessment of changes and deviations during manufacturing for their impact on validation
• Education: Master Degree in Chemistry or Biotechnology (PhD preferred)
• Proficiency in writing scientific reports in English & Experience in GMP manufacture preferred. At least 5 years experience in QA, with experience in Management of CAPAs.
• Fluency in English and German required
• Managing internal and external customer relations professionally and effectively