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Associate QA Validation Manager



Associate QA Validation Manager
Limerick, Ireland
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Job ID: JOB-13251

Associate QA Validation Manager

Our Limerick based Bio-Tech Client are seeking an Associate Quality Assurance Validation Manager to join their team on a permanent basis. This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards and oversees a team of Validation Specialists.

  • Manage, develop and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation.
  • Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines.
  • Ability to lead multiple and sophisticated validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.
  • Lead technical and quality investigations.
  • Collaborates with functional departments to resolve issues.
  • Manage a cross-functional project with many stakeholders
  • Reviews, edits and approves change controls, SOPs, reports and other documentation
  • Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
  • Trains/advises less experienced Specialists.
  • May present at both internal and external (regulatory) audits if required.
  • Stays current with industry trends, regulatory requirement updates, and presenting same to team
  • Performs other duties assigned by Management.
  • Some travel may be required.

Key Requirements

  • BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of related experience within the field preferred; may substitute relevant experience for education.
  • Previous team/people management experience essential.
  • Previous cleaning validation and steam in place experience an advantage.
  • Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage.

For further information on this role in please contact Mark Wilson on 0860449473 or email [email protected]

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Mark Wilson


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