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.
•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