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Details

Senior QC Associate - BioAnalytical Sciences


Reference:SMC028659 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst, Nurse Associate

Summary

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Dublin. 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

• Experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Participate in the peer review of analytical data.
• Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of job as required.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure the laboratory is operated in a safe manner
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
• Participate in regulatory agency inspections as required.

Education & Experience

• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
• Have experience in a pharmaceutical/healthcare Laboratory.
• Experience in Bioassays, Immunoassays and Cell Culture is essential.
• Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage

If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480