Contract QC Analyst role Cork

Duties:
• Trains other QC analysts in laboratory methods and procedures when required.
• Performs analytical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR USP and EP guidelines.
• Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
• Writes, executes, reports and reviews IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use.
• Performs routine and non-routine analytical testing activities.
• Review and approval (where appropriate) of laboratory test results.
• Ensures that testing and results approval are completed within agreed turnaround times.
• Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
• Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards.
• Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
• Anticipates and plans for future requirements in the area.
• Deals with non-conformances/ deviations in an accurate and timely manner.
• Deputizes for the QC Team Leader as appropriate.
• Maintains and develops knowledge of analytical technology as well as cGMP standards

ESSENTIAL:
• A third level qualification in a scientific/technical discipline required.
• A minimum of 2 years experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.