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Responsible Process Validation (manager)

Ref: JN-072021-183691

Gepostet am 18 August 2021
Job Location
Life Sciences

Modis is looking on behalf of a client for an experienced QA Manager involved in projects of process characterization.


Your Tasks:

• 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

Your profile:

• 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