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QAV Specialist – Process Equipment

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. Compliance / Quality Assurance
06-02-2024
32783

This vacancy has now expired

QAV Specialist – Process Equipment - Pharmaceuticals - Copenhagen - 12-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.


The successful QAV Specialist will be responsible for:
  • The QAV Specialist for the Project will be supporting the direct impact equipment vendor assessments and support the PQA review and approval of the CQV documentation.
  • In addition will help with the Early work Quality Activities such as:
    • Approval of Change Management Records
    • FMEA support
    • Coordinate Training
    • Support the review and approval of construction documentation, perform P&DS walk-throughs, risk assessment and construction activities that required PQA assistant.
    • Support the review and approval of all CQV generated documentation, including but not limited to; URS’, EDR-DQ, SIA, FAT Wraparounds, RTM, QRA, RV, SAT, IOC, IOQ and Final Reports.
    • Align with CQV Project Manager on CQV process to be utilised on Project. With consideration given to ASTM E2500, Grouping, Family Approach and Leverage approach, towards testing for all Systems, from FAT-IOQ.
    • Support GMP reviews on behalf of client, at 30%, 60% and 90%, manage and close all actions generated from GMP reviews.
    • Support the Turnover package reviews, both Vendor and Contractors. Align with CQV in relation to documentation deliverables for Vendor Data Requirements (VDR) and Table of Content (TOC).
    • Ensure QA pre-approval on all direct impact documentation, to fully align with Project Leveraging philosophy.
    • Support the review of Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
The ideal candidate will possess:
  • Minimum 7 years QAV Biotech experience on Large Scale Projects
  • SME on all Quality and Compliance issues - minimum 7 years
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Minimum of 7 years of Biotech experience including experience with design and construction projects for biopharmaceutical 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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