Job Description
We are seeking a highly skilled Quality Control Analyst to join our team at an award-winning Pharmaceutical organization based in Cork.
This is an excellent opportunity for individuals who want to work with a leading multinational company that excels in its field.
Duties and Responsibilities
* Achieve a high level of competency in laboratory methods and procedures to support in-process and release testing of biotechnology products.
* Review and approval of laboratory test results.
* Perform analytical testing activities related to method validation and technical transfer to ensure compliance with ICH, USP, and EP guidelines.
* Execute validation, operation, maintenance, calibration, and troubleshooting of equipment and associated software.
* Write and execute reports, and review IQ/OQ and PQ protocols to ensure qualification of equipment for cGMP use.
* Ensure timely completion, review, and approval of all testing within agreed turnaround times.
* Maintain quality control activities in accordance with product license commitments, cGMP, and company quality standards.
* Train other QC analysts in laboratory methods and procedures as required.
* Develop, update, and review TMs, SOPs, and WIs as needed.
* Investigate and document invalid assays, non-conformances, and deviations as required.
* Promote lean initiatives such as Kaizen, 6S, and Gemba within the QC group.
* Participate actively in QC group activities and provide assistance as needed.
* Communicate relevant issues to the QC Team Leader promptly.
* Maintain and develop knowledge of analytical technology and cGMP standards.
Education and Experience
* Bachelor's degree (Honors) in a scientific or technical discipline.
* At least two years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
* Experience with HPLC, Capillary Electrophoresis, UPLC/Mass Spec techniques.
Please contact us for further information on this opportunity.