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QA Validation Specialist required for expanding biotech site in Sligo town. The successful candidate will have prior Validation experience in equipment, facilities and utilities in a GMP environment.
Get in touch with me for further information : Deirdre Murphy on 01 / or
1. Site QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk.
2. Review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.
3. Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
4. QMS areas of responsibility include Deviation investigations, Change Control and CAPA management systems; Internal/External audits; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials.
5. Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility.
6. Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
7. Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
8. Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA
9. Act as the QA lead in QA activities in project work-streams involving cross-functional, multi-department teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
10. Actively contribute to continuous improvement activities.
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