Global Pharmaceutical company based in Limerick, Ireland - looking for QA Representative (Quality Engineer)
This would be a 12+ month contract position, full-time, (based full time on the site) with possible contract extension.
The Role:
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.
Bench‑marking 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 escalation of 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.
Qualifications:
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, etc.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
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