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Job Description
Join a leading multinational pharmaceutical organization in Cork as a laboratory analyst, responsible for ensuring the quality of biotechnology products.
Key responsibilities include:
- Developing and maintaining laboratory methods and procedures to support in-process and release testing.
- Reviewing and approving laboratory test results to ensure compliance with ICH, USP, and EP guidelines.
- Performing analytical testing activities for method validation and technical transfer.
- Executing validation, operation, maintenance, calibration, and troubleshooting of equipment and software.
- Writing and executing reports, reviewing IQ/OQ and PQ protocols, and ensuring equipment qualification for cGMP use.
- Ensuring timely completion, review, and approval of testing activities.
- Conducting QC activities in compliance with product license commitments, cGMP, and company quality standards.
- Training other QC analysts in laboratory methods and procedures.
- Developing and reviewing technical documents, including TMs, SOPs, and WIs.
- Participating in lean initiatives, such as Kaizen, 6S, and Gemba.
- Collaborating with the QC group and providing assistance with group activities.
- Maintaining and developing knowledge of analytical technology and cGMP standards.
Requirements:
- BSc (Honors) in a scientific or technical discipline.
- 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
- Experience with HPLC, Capillary Electrophoresis, UPLC/Mass Spec.