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Leader for CQV (pharma)

Ref: JN-082021-192286

Gepostet am 16 August 2021
Job Location
Life Sciences

Modis is looking for a leader for the commissioning and qualification activities on behalf of a client.

Your Tasks:

  • Lead and direct the Commissioning and Qualification team Responsible for the compliance of all industrial assets, ensuring that the equipment meets regulatory requirements.
  • Compliant implementation of new systems through the engineering project phase Maintaining compliance of existing systems by delivering appropriate re-qualification and periodic review
  • Building compliant processes covering all aspects of the equipment lifecycle (VMP, VPP‘s, specifications, DQ, FAT/SAT, IQ, OQ, PQ & PPQ, requalification and periodic review)
  • Design and implement execution strategies, ensure that adequate budget (opex and capex) is planned and spent in support of the C&Q team

Your Skills:

  • Master’s degree in Process-, Chemical–, Mechanical- or Bio Engineering
  • 10+ year experiences in Commissioning, Qualification and Validation within the pharmaceutical or biotechnology sector Significant experience of leading C&Q teams in the pharmaceutical industry including biopharmaceutical, sterile fill finish and utility qualification activities, black and clean utilities, Computer Systems Validation,
  • Act as a Subject Matter Expert in FAT (SAT) planning and execution
  • English fluent, German higly preferd