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CQV Lead – Sterile Drug Product Labs

  1. Dublin
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
14-09-2023
32171
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CQV Lead – Sterile Drug Product Labs - Dublin 

Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a globally renowned biotechnology organisation, and voted one of the top 10 best companies to work for in Ireland, is looking to recruit a CQV Lead to join their team.

Roles and Responsibilities:
  • Act as CQV subject matter expert for sterile lab. / Act as CQV Subject matter experience for HVAC & Clean room
  • 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.
  • Experience with Lab Sterility Isolators, Cold Rooms, BSCs, Fume-hood and Fridges & Freezers. / experience with HVAC & Clean room
  • 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 CQV deliverables; IOQ, field execution
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports.
  • Review and approve vendor documentation.
  • Witness vendor qualification activities (FAT, SAT and IOQ).
  • Define DQ,IQ,OQ, PQ, PPQ qualification strategy.
  • Document and supervise qualification activities.
  • Define and compile defects libraries for qualification.
  • Oversee and coordinate the generation of bridging datA.
Work Experience Requirements:
  • Experience with Lab Sterility Isolators, Cold Rooms, BSCs, Fume-hood and Fridges & Freezers.Familiar with and regulatory requirements (minimum US and EMA).
  • Minimum of 8-year experience in the pharmaceutical industry, preferably in sterile labs, QC and/or Production.
  • Team player with strong communication skills
  • Experience in coordinating diverse teams within a matrix environment.
  • Good technical writing skills
  • Reliable execution

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

The candidate must have the rights to work in the location stated in the job advert.

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