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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:
- Develop and maintain a high level of competency in laboratory methods and procedures to support in-process and release testing.
- Review and approve laboratory test results to ensure accuracy and compliance with ICH, USP, and EP guidelines.
- Perform analytical testing activities, including method validation and technical transfer, to ensure methods meet regulatory requirements.
- Execute validation, operation, maintenance, calibration, and troubleshooting of equipment and software.
- Write and execute reports, review IQ/OQ and PQ protocols, and ensure all relevant equipment is qualified for cGMP use.
- Ensure testing is completed, reviewed, and approved within agreed turnaround times and in compliance with product license commitments and company quality standards.
- Train other QC analysts in laboratory methods and procedures as required.
- Write, update, and review technical documents, including TMs, SOPs, and WIs.
- Participate in quality improvement initiatives, such as Kaizen, 6S, and Gemba.
- Communicate relevant issues to the QC team leader and maintain 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.