QA Representative (Engineering)
Berkley Group View all jobs
- Limerick
- Contract
- Full-time
- Quality oversight of and guidance on capital projects.
- Maintenance of all aspects of GMP compliance for the area(s) of responsibility.
- Establishment, maintenance and management of a control system for the specific Quality System(s)/Program.
- Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program.
- Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program.
- Review and approval of change controls and failure investigations, associated with the area(s) of responsibility.
- Reports and escalate critical quality issues to the appropriate level of quality management for final resolution.
- Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, GMP utilities and periodic quality evaluations.
- Review and approval of other key GMP documents such as GMP standard operating procedures, specifications, process flow diagrams as appropriate to area of responsibility.
- Monitoring GMP compliance, GMP programs and systems by ensuring a regular presence in area of responsibility.
- Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.
- Bachelor's degree in Engineering
- Strong experience in GMP - regulated pharmaceutical or biotech environments.
- Demonstrate experience in Quality oversight on capital projects and all aspects of GMP compliance.
- Quality system programs.
- Review and approval of other key GMP documents.
- Experience with Quality Oversight areas in Utilities, Facilities, Equipment, ext.