Our client, a highly respected pharma company are looking for a QC Analyst to join their team in Cork. This position is to support the Separations team and will involve CIEF testing, HPLC and CSDS testing.
Achieves competency in laboratory methods and procedures.
Trains other QC analysts in laboratory methods and procedures when required.
Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that 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 that all relevant equipment is qualified for cGMP use.
Performs routine and non-routine analytical testing activities.
Review and approval (where appropriate) of laboratory test results.
Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
Basic Minimum Qualifications & Experience:
A third level qualification of a scientific/technical discipline is required.
Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
HPLC experience within a GMP environment is essential.