We’re currently recruiting for an exciting opportunity with an award winning biopharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
• Achieves competency in laboratory methods and procedures.
• Trains other QC analysts in laboratory methods and procedureswhen required.
• Performs analytical testing activities in relation to methodvalidation and technical transfer activities to ensure that allmethods meet ICH, USP and EP guidelines.
• Executes validation, operation, maintenance, calibration andtroubleshooting of equipment and its associated software.
• Writes, executes, reports and reviews IQ/OQ and PQ protocols toensure that all relevant equipment is qualified for cGMP use.
• Performs routine and non-routine analytical testing activities.
• Review and approval (where appropriate) of laboratory testresults.
• Ensures that testing and results approval are completed withinagreed turnaround times.
• Writes and reviews laboratory TMs, SOPs and WIs as directed bycompany policy.
• Ensures QC activities are carried out in compliance with productlicense commitments, cGMP and company quality standards.
• Is an active member of the QC group and provide assistance withother group activities as required and communicates relevantissues to the QC Team Leader and Manager.
• Deals with non-conformances/deviations in an accurate andtimely manner.
• Deputizes for the QC Team Leader as appropriate.
• Maintains and develops knowledge of analytical technology aswell as cGMP standards.
• In process control testing and activities to support the productionunits.
Education & Experience
• A third level qualification of a scientific/technical discipline isrequired.
• Knowledgeable of FDA/EMEA regulatory requirements applicableto biologics and/or pharmaceuticals.
•Key analytical technique required: HPLC
•Other desirable techniques: A280 and Nephelometry testing, residual protein assay, TOC analysis
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480