We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties

•Execute and or support vendor IQ/OQ/PQ protocols

•Establish IQ/OQ/PQ processes and execute for laboratory instrumentation and controlled temperature units.

• Support vendor IQ/OQ/PQ

• Develop and write protocols for instrument qualification/validation studies.

• Assist in performing instrument qualification/validation assessments.

• Help troubleshoot instrument performance issues.

• Complete instrument related documents.

• Document results and write summary reports of instrument uses and qualification studies.

• Support and organize new instrument evaluation and purchase activities.

• Produce and maintain accurate and GMP compliant records.

• Support change control activities impacting QC equipment

• Perform impact assessments when required.

• Perform investigations of equipment related deviations as needed.

• Write/Review SOPs relevant to laboratory instrument and software operation.




Education & Experience


•Requires BS/BA in a Science discipline;

• At least 1 years relevant experience in a cGMP environment is required

• Experience with executing IQ/OQ/PQ protocols and a working knowledge of Trackwise, would be an advantage