JO-2506-552925
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 01 614 6178 / 087 180 4358 or [email protected]
- 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.
- 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.
- Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
- 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.
- Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility.
- Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
- Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
- Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA
- 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.
- Actively contribute to continuous improvement activities.
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