Quality Control Analyst

PE Global is currently recruiting for a QC Analyst for a leading multi-national Pharma client based in Co Cork.

This a contract position.

Role:

• 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.

  SPECIFIC TESTING EXPERIENCE REQUIRED
  • HPLC
  • Capillary Electrophoresis
  • UPLC/Mass Spec (desirable)

Requirements:

• BSc (Honors) in a scientific/technical discipline.
• A minimum of 2 years’ experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory

Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up to date CV to Niamh.mcdonald@peglobal.net.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***