Role Denmark

PQA Engineer

  • Posted Jun 15, 2023
  • Denmark
  • Contract
  • BBBH26627

LSC has a fantastic opportunity for a PQA Engineer to join an advanced global team in Denmark that promotes self-development, encourages collaboration, and fosters a learning environment. The company specialises in clinical & commercial manufacturing of Biotech medicines, including viral gene therapies and has built a strong reputation over the years for bringing complex and lifechanging therapies into reality. This is a chance for you to be a part of a fast-growing, multicultural company that has a compelling vision for shaping the future of medicine. ABOUT THE PROJECT - KEY RESPONSIBILITIES:
  • Primarily Quality support for CIP Skids and associated CIP Loops
  • Support the direct impact equipment vendor assessments and support the PQA review and approval of CQV documentation.
  • Support the review and approval of construction documentation, perform P&ID walkdowns, risk assessment and construction activities that required PQA assistance.
  • 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-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).
  • Minimum 5 years QAV Biotech experience on Large Scale Projects - CIP
  • SME on all Quality and Compliance issues - minimum 15 years - CIP
  • Working knowledge of ASTM E2500 / Leveraging Verification process
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Sarah Ninan at +353 214771329 if you have any more questions about this opportunity!

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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