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  • NO. 6,
  • CORK
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  • Job reference number:15330352
  • Client ID:RI/BBBH688701
  • Posted on:08-MAR-2018
  • Location:CORK, CORK
  • Job type:PERMANENT

Are you looking for an exciting new opportunity within QC? A leading global pharmaceutical company based in Cork is looking for an experienced QC Analyst to join their team

Role and Responsibility:

  • Carry out routine and non-routine analytical testing activities.
  • Train 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.
  • Review and approval (where appropriate) of laboratory test results.
  • 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.
  • Deals with non-conformance's/ deviations in an accurate and timely manner.
  • Maintains and develops knowledge of analytical technology as well as cGMP standards.

Skills and Experience:

  • Third level degree in Science related discipline
  • Minimum 4 years experience within GMP
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and pharmaceutical essential

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

This job originally appeared on RecruitIreland.com