We are currently recruiting for an exciting opportunity with a leading pharmaceutical organization based in Cork. This position is ideal for individuals seeking to join a multinational renowned for excellence.
Duties
* Achieves a high level of competence in laboratory methods and procedures to support process and release testing of biotechnology products.
* Reviews and approves laboratory test results.
* Performs analytical testing activities in relation to method validation and technical transfer activities to ensure all methods meet ICH, 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 to ensure relevant equipment is qualified for cGMP use.
* Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
* Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
* Trains other QC analysts in laboratory methods and procedures when required.
* Actively participates in JSI lean initiatives such as Kaizen, 6S and Gemba.
* Is an active member of the QC group and provides assistance with other group activities as required.
* Communicates relevant issues to the QC Team Leader promptly.
* Maintains and develops knowledge of analytical technology as well as cGMP standards.
Education & Experience
* BSc (Honors) in a scientific/technical discipline.
* 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
* HPLC, Capillary Electrophoresis, UPLC/Mass Spec experience.