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QA Validation Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Scientific
  • Date posted: 06/11/2018
  • Job reference: BBBH92111

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QA Validation Manager

My client, an industry leader in biopharmaceuticals is currently seeking a QA Validation Manager to join their team.

In this position you will be tasked to 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. You will also be required to 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 manage multiple and complex 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 projects with many stakeholder
  • 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.

Education and Experience:

  • BS/BA in Engineering, Chemistry, or Life Sciences with 6+ 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 more information on this and other potential opportunities please contact Kathryn for a confidential discussion on 016455250.