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Senior Validation Expert
3 weeks ago
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