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CQV Lead

  1. France
Toulouse
  1. Contract
Competitive
  1. CAPEX Projects
34692
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CQV Lead - QC Labs - Drug Substance - Toulouse, France  

Our client, a global biotechnology organisation, is recruiting for a CQV Lead to join their capital project in the South of France. This new build facility will house a therapeutic protein production plant, and we are looking for a CQV Lead to help expand our client's biotech operations throughout Europe. As the CQV Lead you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.


Responsibilities: 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Systems to support Equipment Start-up and IOQ Testing.
  • Lead CQV interface with EIDA / or Master Project Database equivalent system, ensure full traceability at all times for all systems.Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Systems are managed appropriately for the Project Lifecycle.
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Ven. or Assessments/FAT/SAT/CTP/IOQ Protocols Lead execution of all LSCC CQV deliverables; IOQ, field execution
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports

Requirements:
  • Relevant degree
  • CQV Lead experience with QC Labs environment. Ability to set up a biotech lab from a CQV point of view and get it ready for handover. 
  • EMPQ experience and CQV Lead experience. 
  • Experience including experience with design and construction projects for biopharmaceutical manufacturing facilities. 
  • Experience in Leading CQV Team   
  • Experience with complex projects and working in or around operating facilities.
  • Experience within QC lab – equipment and CQV set upAbility to keep work pace and meet deadlines.
  • Good organizing and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, local vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
  • Nice to have: French but not required. 

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

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