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CQV Lead

  1. Germany, Frankfurt
Frankfurt ( Oder)
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37549
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CQV Lead - Germany, Frankfurt - 18 Month Contract 

We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Frankfurt. Due to a large capital investment and multiple projects on site, the client is looking for a CQV Lead Autoclave and Temp Mapping to join their team.

Responsibilities include:
  • Lead the cycle development and qualification of pharmaceutical sterilisation processes, including
  • moist heat and Atec Component Processors.
  • Execute temperature and thermal mapping protocols in accordance with industry regulations and
  • internal quality systems.
  • Collaborate with cross-functional teams (Engineering, QA, Automation) to develop and review URS,
  • FDS, and high-level specifications.
  • Manage the qualification life cycle of autoclaves and other sterilisation equipment (FAT/SAT, IQ,
  • OQ, PQ).
  • Perform troubleshooting, deviation investigations, and corrective actions related to sterilisation or
  • utility validation processes.
  • Support GMP documentation processes, including protocol authoring, execution, and final
  • reporting.
Key requirements include:
  • Requires extensive experience of validation/CQV experience in the pharmaceutical or biotech industry.
  • Proven experience with cycle development, autoclave qualification, and temperature mapping.
  • Familiarity with cleanroom environments, containment systems, and GMP compliance.
  • Strong understanding of commissioning documentation and qualification protocols (IQ/OQ/PQ).
  • Excellent communication skills and ability to work cross-functionally in a regulated environment.
If you are local to Frankfurt and interested in discussing this position, please submit your profile and we will be in contact at our earliest convenience.

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