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CQV Coordinator

  1. Brussels
Brussels
  1. Contract
Competitive
  1. CAPEX Projects
02-09-2024
34931
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CQV Coordinator – Brussels – Contract – Pharmaceuticals

We are looking for an experienced CQV Coordinator for a fantastic 12 month contract based in Brussels.

Working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease, you will act transversely as CQV C&Q Coordinator across a number of CQV processes as described below:
  • CQV Change management, coordinate, support and coach CC initiators on CQV aspects.
  • CQV punch management
  • CQV non-conformance management
  • Dashboard / KPI management, reporting for CQV
As well as:
  • As needed, Draft or support the document drafting, coordinate review and approval of applicable C&Q documents (QRA/DV/RTM/FAT/SAT/IOV/VSR) following approved VMP and SLIA.
  • Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s).
  • Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
  • Ensures Start-up of equipment/ system is completed in a safe and coordinated manner.
  • Generate and or review change controls related to C&Q and drive their closure in a timely manner
Experience Required
  • End to end experience with this equipment in International CAPEX C&Q.
  • Technical qualification at third level or equivalent in Engineering
  • Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects including automation related aspects of equipment.
  • Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
  • Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution.
If this role is of interest, please apply now.

 #LI-CB1

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