Sligo – Permanent
I am looking to speak with candidates with Quality Engineering or QA specialist experience in a GMP Quality environment for a growth role in this expanding company.
The successful candidate will support the review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and ongoing manufacturing.
Day to day duties
1. Review and approval of validation documentation and activities
related to the qualification of the facility, equipment, and utilities to support start-up and ongoing manufacturing.
2. Manage assigned areas of Quality Management System (QMS)
to ensure the manufacture of product in accordance with GMP and regulatory requirements.
3. QMS areas of responsibility include Deviation investigations, Change Control and CAPA management systems; Internal/External audits; Vendor Management; review/approval of Manufacturing Batch Records and assessment/approval of production materials.
4. Generate, review, and approve SOPs/other documentation as applicable to your areas of responsibility.
5. Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
6. Ensure schedules for review and approval of GMP/validation documents are maintained to support technology transfers and new product introduction project timelines.
7. Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA.
8. 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.
9. Actively contribute to continuous improvement activities.
For a confidential chat, please reach out to [email protected]
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