Collins McNicholas currently have an exciting opportunity for a QA Validation Manager – Cleaning & SIP with one of their clients in the Mid-West Region. This role is a permanent position.
Summary: 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
The following are the key requirements for the role:
- 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.
- 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 a confidential discussion on the above role please contact Michael O’Leary on 061-512270