CQV Lead

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Job type
Contract
Location
Copenhagen, Denmark
salary
Competitive
Ref. No
40135
CQV Lead - Denmark - 6 Month Contract

Our client, a global pharmaceutical company, are looking for a CQV Lead to join their team. The company has grown to become a world leader in the development, manufacture, and marketing of innovative pharmaceutical products to alleviate some of the world’s biggest health problems.

What you'll do:
  • Develop the full CQV strategy, including scope, sequencing, system classification, and alignment with project milestones
  • Provide CQV input into early design decisions, ensuring requirements for fermentation, recovery, filtration, chromatography skids and utilities are incorporated
  • Lead creation and oversight of all CQV documentation (URS, DQ, IQ, OQ, PQ, traceability matrices, impact assessments, system boundaries, CQV master plan)
  • Define system ownership and turnover packages, ensuring clear boundaries between process, utilities, and facility systems
What you'll need:
  • Must have led CQV on a €100M drug substance/API project.
  • Strong background and experience with process equipment to facilitate fermentation, recovery, filtration, and chromatography in API Produciton
  • Experienced in brownfield environments (demolition, decommissioning, retrofit).
  • “Mid-range” seniority (not too junior, not overly senior/strategic)
If you would like to apply or find out more, get in touch now!
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Liam Harrington
Senior Business Development Lead
Liam Harrington