Job Summary: We're recruiting for a Pharmaceutical organization in Cork. This is an excellent position for anyone who wants to join a leading multinational.
Key Responsibilities:
• Achieves high competency in laboratory methods and procedures to support testing of biotechnology products.
• Reviews and approves laboratory test results.
• Performs analytical testing activities to ensure 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 equipment is qualified for c GMP use.
• Ensures testing is completed, reviewed and approved within agreed turnaround times.
• Ensures QC activities are carried out in compliance with product license commitments, c GMP and company quality standards.
• Trains other QC analysts in laboratory methods and procedures when required.
• Writes/updates and reviews TMs, SOPs and WIs as required.
• Actively participates in QC group activities and provides assistance as required.
• Maintains and develops knowledge of analytical technology as well as c GMP standards.
Requirements:
• 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.