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QA Validation Specialist

Job description

My pharmaceutical client based in Dublin is looking for a QA Validation Specialist to join a high performing team.
You will be responsible for the coordination of validation activities for the Cell Therapy facility on site ensuring compliance with current regulatory requirements. The role will primarily liaise and support the Cell Therapy Manufacturing facility. 
Responsibilities
  • Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:
  1. Qualification of premises, equipment and utilities.
  2. Computer system qualification.
  3. Laboratory equipment validation.
  4. Process validation.
  5. Cleaning validation.
  • Prepare and maintain policies and SOPs associated with validation.
  • Ensure that all change controls are assessed for impact on validation.
  • Review and Approval of validation master plans.
  • The QA Validation will execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities.
  • Participate in cross-functional project teams as the validation representative.
  • Participate in other projects as directed by the Quality Systems & Compliance Manager.

Requirements

  • Third level degree in a scientific discipline
  • 5 years’ experience working within quality in the pharmaceutical industry

Please call TJ Vinod on +353 21 235 9144 or email tvinod@sigmar.ie for a confidential discussion.

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