We are currently seeking a highly skilled and motivated Quality Control (QC) Analyst to join our award-winning Pharmaceutical organization based in Cork. This is an exciting opportunity for individuals who want to work with a leading multinational company known for its excellence in the industry.
Duties:
* Develops high levels of competency in laboratory methods and procedures to support in-process and release testing of biotechnology products.
* Reviews and approves laboratory test results to ensure accuracy and quality.
* Performs analytical testing activities related to method validation, technical transfer, and equipment maintenance to meet ICH, USP, and EP guidelines.
* Executes validation, operation, maintenance, calibration, and troubleshooting of equipment and associated software.
* Writes and executes reports, reviews IQ/OQ, and PQ protocols to ensure cGMP compliance.
* Ensures timely completion, review, and approval of testing within agreed turnaround times.
* Maintains QC activities in accordance with product license commitments, cGMP, and company quality standards.
* Trains other QC analysts in laboratory methods and procedures as needed.
* Updates and reviews Technical Monographs, Standard Operating Procedures, and Work Instructions as required.
* Documents and reviews invalid assays, non-conformances, and deviations as necessary.
* Participates in Lean initiatives such as Kaizen, 6S, and Gemba to drive continuous improvement.
* Maintains active membership in the QC group and provides assistance with other group activities as required.
* Communicates relevant issues promptly to the QC Team Leader.
Education & Experience:
* BSc (Honors) in a scientific/technical discipline.
* At least two years of experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
* Experience with HPLC, Capillary Electrophoresis, UPLC/Mass Spec technology.