Senior QA NPI Specialist

Senior QA NPI Specialist - Ireland, Dublin - 12 Month Contract

Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Senior QA NPI Specialist to support their Dublin project.  

What you'll do:

• Ensure Commissioning readiness of all Black Utility Systems to support Equipment Start-up and IOQ Testing.
• Act as CQV SME on Utility systems
• Lead CQV interface with KNEAT / EIDA / or Master Project Database equivalent system, ensure full traceability at all times
• 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.

What you'll need:

• Extensive experience within the pharma industry or a related field.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
• Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. 

If this role is of interest, please apply now.

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