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CQV Lead

  1. England, Yorkshire
York
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37225
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CQV Lead - UK, York - 6-12 Month Contract 

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Lead to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.

Responsibilities include:
  • CQV Lead Engineer with responsibility for creating and documenting CQV procedures, CQV strategy and grouping strategy.
  • Review of all GMP generated documentation.
  • Point CQV person for Vendor review for Vendor Packages.
  • CQV SME for Facilities and supporting utilities etc.
  • Lead CQV effort for schedule review and readiness. 
  • Liaise with Project CQV Lead and Lead Scheduler in relation to schedule readiness and tracking.
  • Responsible for leading the client-side team to deliver verification of Facilities and Utilities utilizing data from CTOPs and generated during the commissioning executed by the main contractor.
  • Provide oversight of vendor / main contractor testing.
  • Strong Kneat competency essential.
Key requirements include:
  • Extensive experience including experience with design and construction projects for Facilities and utilities on biopharmaceutical manufacturing facilities. 
  • Experience with complex projects and within a CQV Lead capacity taking responsibility for setting the strategy and direction on a project.
If this role is of interest, please apply now!
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