We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical 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.
This position is responsible for carrying out tasks and projects related to
equipment, lab utilities and testing procedures as required by Good
Manufacturing Practice (GMP). Partners with other Departments to ensure
that all QC testing activities are completed in an efficient manner.
• 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
• Ensures that testing and results approval are completed within
• agreed turnaround times.
• Writes and reviews laboratory TMs, SOPs and WIs as directed by
• company policy.
• Ensures QC activities are carried out in compliance with product
• license commitments, cGMP and company quality standards.
• Is an active member of the QC group and provide assistance with
• other group activities as required and communicates relevant
• issues to the QC Team Leader and Manager.
• Deals with non-conformances/ deviations in an accurate and
• timely manner.
• Deputizes for the QC Team Leader as appropriate.
• Maintains and develops knowledge of analytical technology as
• well as cGMP standards.
• In process control testing and activities to support the production
Education & Experience
• A third level qualification of a scientific/technical discipline is
• Knowledgeable of FDA/EMEA regulatory requirements applicable
• +2 Experience with HPLC in QC enviroment under GMP guidelines
If you would like further Information you can contact the recruiter directly:
Jack Caffrey | Tel: +353 (0) 1 507 9279