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Project QAV Lead

  1. Denmark
  1. Contract
Competitive
  1. CAPEX Projects
14-02-2024
32915
Project QAV Lead - Copenhagen - 6 Months 

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Project QAV Lead to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.


Responsibilities:

  • Lead up the Drug Product Project QA (PQA) through SAT, IQ, OQ and PQ activities
  • Be very visible in the project and Drug Product organisation and therefore have strong stakeholder management skills
  • Create, approve and maintain quality plans and procedures
  • Review and approve SAT/IQ/OQ and PQ for major process equipment e.g. filling line (preferable) or automatic inspection machine
  • Continuous align with CQV Project Lead on CQV process to be utilised on the project with consideration given to ASTM E2500 and leveraging from FAT into IOQ
  • Review and approve updates to Validation Project Plans covering Process-and support equipment IT/Automation, clean utilities and facility
  • Aligning with the DP Project Manager and project leads on requirements, maintain and manage PQA team for the duration of the project, both planning and forecast costing for the team
  • QA involvement in clean room area readiness and qualification
  • Oversight over project change management planning and execution

Requirements:

  • You have +10 years of QA for engineering/validation experience including experience with design and construction projects, preferable with fill-finish equipment and facility
  • Strong leadership skills with knowledge on how to set the direction for the project regarding quality
  • Working knowledge of principles, concepts, and practices of ASTM E2500 / Leveraging Verification process
  • Experience with qualification formulation, filling and/or automatic visual inspection equipment
  • Deep cGMP knowledge.
  • Fluent in English both verbally and in writing
  • Master of Science within Pharmacy, Biotechnology, Biology, Technical Engineering or similar

If this role is of interest to you, please apply now! 
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