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QAV Specialist

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. CAPEX Projects
10-05-2024
33839
QAV Specialist - Pharmaceuticals - Copenhagen - 6-Month Contract

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a QAV specialist 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:

  •  Support and manage SAT, IQ, OQ and PQ activities.
  • Create, approve and maintain quality plans and procedures, risk assessments, reports and support inspection readiness
  • Ensure coordination of Commissioning and Qualification activities for the defined equipment in charge with qualification matrix according to planning, cGMP conformance and internal Standards
  • Review and approve SAT/IQ/OQ and PQ for major process equipment, primarily the isolator based filling line
  • 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, Risk assessment, change control management, covering Process-and support equipment IT/Automation Scada, clean utilities and facility.
  • Aligning with the DP PQA Team and project leads on requirements
  • QA involvement in clean room area readiness and qualification
  • Participate to oversight over project change management planning and execution


Requirements:
  • Minimum 5 years QAV Biotech experience on Large Scale Projects
  • SME on all Quality and Compliance issues - minimum 5 years
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Minimum of 5 years of Biotech experience including experience with design and construction projects for manufacturing facilities.
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organising and planning skills.
  • This individual must have had experience of a similar project with a multi-million capital spend.

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

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