Did you know that your Internet Explorer is out of date?To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.Name:Surname:Email:Phone:Cv:Salary Expectations:Education:Experience:Current Location:Notice Period:Write here your cover note:If you would like us to create a jobseeker account for you, giving you access toaccount management, job alerts and one-click applications, then please tick this boxIf you are having difficulty you can always email your cv to applications@lifescience.ieWe’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.Duties• Achieves a high level of competency in laboratory methods and procedures to support in process and release testing of biotechnology products.• Review and approval of laboratory test results.• 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 it’s associated software.• Write/executes reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.• Ensures that all testing is completed, reviewed and approved within agreed turnaround times.• Ensures QC activities are carried out in compliance with product license commitments, cGMP 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.• Writes and reviews invalid assays, non-conformances and deviations as required.• Actively participates in JSI lean initiatives such as Kaizen, 6S and Gemba.• Is an active member of the QC group and provide assistance with other group activities as required.• Communicates relevant issues to the QC Team Leader promptly.• Maintains and develops knowledge of analytical technology as well as cGMP standards.Education & Experience• 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 experienceIf interested in this posting please feel free to contact Sean McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.
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