QA Representative (Engineering)

Global Pharmaceutical company based in Limerick, Ireland – looking for QA Representative (Quality Engineer)

This would be 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 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.

Have You:

* 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.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com