Job Description A QC MICRO ANALYST is required by CareerWise Recruitment for our multinational biopharmaceutical client in Cork for a fulltime, shift role on an initial 12-month contract.
The QC MICRO ANALYST will be responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by Good Manufacturing Practice (GMP).
Role of this position Performs analytical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR 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 so as to ensure that all relevant equipment is qualified for cGMP use.
Performs routine and non-routine analytical testing activities.
JOB REQUIREMENTS Bachelors Degree (Level 8) in Science, or related Technical discipline.
A minimum of 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.