Excellent new opportunity for a Manager - QA Validation.
This is a permanent opportunity with a top multinational in Limerick.
This successful candidate will implement policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards and oversee 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.
- 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.
- Some travel may be required from time to time.
- BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years relevant experience within the Biopharma or Pharma industry; 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.
Please call Michelle Galvin today for further information on 091 373 938 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)