QA Validation Manager
CAREERWISE RECRUITMENT
Limerick, Ireland
2d ago

Job Description

QA VALIDATION MANAGER (CLEANING & SIP) required by CareerWise Recruitment for our multinational BioTech client in Limerick.

The QA VALIDATION MANAGER (CLEANING & SIP) 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.

Role of this position

  • 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 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 communicating same to team.
  • Performs other duties assigned by Management.
  • Some travel may be required.
  • REQUIRMENTS :

  • 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.
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