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QA Validation Specialist

Job description

Summary

Provide quality oversight on design and qualification activities as part of the introduction of new equipment and modification of existing equipment in order to facilitate new product introductions.

Responsibilities:

  • Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
  • Quality SME for the execution and reporting phases of the qualification and validation activities associated with the facility.
  • Review and Approve all documentation where required specific to Qualification / Validation activities.
  • Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner
  • Oversee the Project Change Management Process and approve Project Change Requests where required.

Qualifications:

  • Minimum of 10 years’ experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
  • Strong experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
  • Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
  • Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
  • Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.

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