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Senior Validation Expert

3 weeks ago


Cork, Cork, Ireland Pm Group Full time
Job Overview

The Pm Group is seeking a skilled and experienced QA Validation Specialist to join a Client Validation team. This role will be responsible for the review and approval of validation lifecycle activities in a GMP regulated environment.

This includes implementation of new manufacturing processes, equipment, computer systems, laboratory systems, and changes to existing equipment.

Responsibilities:

  • Provide project management oversight from a Quality perspective for FUE activities related to products and facilities, utilities, equipment (FUE)
  • Assist Functional Validation groups in the development of validation plans for specific system implementation projects
  • Review and Approval of project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols) validation activities related to the implementation of facilities, utilities, equipment changes
  • Establish Site Validation Policies, through development, generation, and implementation of validation master plans, guideline documents, and SOPs
  • Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the client, validation techniques/approaches, and systems utilized at the client site
  • Lead and represent Validation in multi-departmental meetings & project teams
  • Identify and implement improvements to the QA Validation systems
  • Participation in the change control program for NPIs, capital projects, and modifications to qualified systems
  • Ensure maintenance of the qualified/validated state within the Revalidation Evaluation and Requalification programmes
  • Review and Approval of validation activities and documentation related to maintenance of qualified / validated states
  • Aess the impact of changes to the validated state of systems/equipment as part of the site change control program