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Job Description
Job Summary:
A Pharmaceutical organization based in Cork is seeking a highly skilled QC Analyst to support the testing of biotechnology products.
Job Description:
- Achieves a high level of competency in laboratory methods and procedures to support in process and release testing of biotechnology products.
- Reviews and approves laboratory test results, ensuring accurate and timely completion.
- Performs analytical testing activities, including method validation and technical transfer, to ensure compliance with ICH, USP, and EP guidelines.
- Executes validation, operation, maintenance, calibration, and troubleshooting of equipment and associated software.
- Writes and reviews reports, IQ/OQ, and PQ protocols to ensure qualification of equipment for cGMP use.
- Ensures 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 as needed.
- Writes, updates, and reviews technical documents, including TMs, SOPs, and WIs.
- Actively participates in QC group activities, providing assistance and support as required.
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.