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CQV Lead

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
26366

This vacancy has now expired

CQV Lead Drug Product Finished Goods - Global Biopharmaceutical Client - USA

Our client is making a significant capital investment for a new biologics facility in the USA and requires a CQV Lead to work on the multi-billion-dollar project.


The Role:
  • Drug Product Filling and Finished Goods packaging including serialisation systems (filling lines, isolator tech, ancillary systems, packaging, serialisation etc.), initially responsible for timely review and approval of all CQV documentation, including but not limited to – EDR-DQ, SIA, FAT, RTM, QRA, RV, SAT, IOC, IOQ and Final Reports.
  • Review of all Design deliverables from EPCM, including Drawings, Datasheets, specifications and Engineering Lists. Also assist in GMP reviews. Author all CQV sub plans (VPP) for Finished goods and drug product Areas. Review of all GMP generated documentation via the KNEAT system.
  • Liaise with the CMMS Team from day 1 to ensure timely transition of GMP information into the CMMS system.
  • Aligning with EPCM and CQV Turnover Lead in relation to System boundaries and Lead and review exercise.
  • Point CQV person for Vendor review for all Finished goods and drug product Vendor Packages.
  • CQV SME for all Finished goods and drug product Systems.
  • Liaise with EPCM in relation to construction readiness and a schedule for all Finished goods and drug product systems.  Lead CQV effort for schedule review and readiness.  Also perform and lead all field walk-downs for all Finished goods and drug product systems.
  • Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Finished goods and drug product Areas. 
  • Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for Finished goods and drug product Systems. 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Finished goods and drug product Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Finished goods and drug product Systems to support Equipment Start-up and IOC-IOQ Testing.
  • Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Finished goods and drug product Systems are managed appropriately for the entire Project Lifecycle.
  • Lead execution of all Finished goods and drug product CQV deliverables; FAT/SAT/CTP/IOQ.
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports.
If this role interests you, apply today. 

 

 



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