Quality Manager with strong GLP, GxP & ISO 13485 experience required by disruptive medical technology client in Dublin. Reporting to the COO, you will lead the implementation of a Certified Quality Management system, maintain GxP compliance and manage internal & external audits. This is a key role within the organisation and will be both hands-on and will also provide operational / strategic input. Do you want to play a part in this growing Irish operation?

Key Responsibilities:

  • Implement and maintain GxP compliance as part of the Integrated Management System
  • Develop and certify against the ISO 13485 Standard in addition to GxP
  • Implementation and execution of Internal Audit process
  • Managing audit process with certification body for ISO 13485
  • Managing client supplier audits and responses on behalf of the company

 

Requirements: 

  • Degree in Life Sciences or equivalent
  • Postgraduate qualifications in Quality Management or Computer System Validation desirable
  • 5-10 years experience in Quality Management role
  • Expert knowledge of GLP / GXP
  • Diagnostics/Medical Device/Pharmaceutical experience required
  • Experience in implementation and execution of an ISO 13485 compliant QMS
  • Key standards of importance include ISO13485, GLP/GCP (OECD GLP, 21 CFR Part 11/58)
  • Regulation of software products for pharmaceutical customers (ideally including Software as a Service) – desirable
  • Experience of GAMP 5 / ISO 9001 would be advantageous

Please contact Emer Smith to discuss in confidence
00353578638188       
emer@emtechrecruitment.ie

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