QC Instrumentation Specialist

Website TPM04798

Summary:
Our client based a global bio pharmaceutical company based in Waterford, is looking for a QC Instrumentation Specialist to join their growing team. This is an amazing opportunity to develop exceptional skills, working with a wide range of analytical instruments across a wide range of laboratories. The successful candidate will plan, execute, and manage the activities required to maintain the testing infrastructure of the QC lab.

Responsibilities:

  • Qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards.
  • Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.
  • Be part of the team responsible for providing a Maintenance Service to the QC laboratory.
  • Support the QC department for troubleshooting, investigations, and deviations as an SME.
  • Manage deviations, CAPA’s and change controls related to the QC and team priorities.
  • Author and revise local SOPs, work instructions, and guidelines.
  • Serve as an SME for regulatory and internal inspections and audits.
  • Review and approve analytical instrumentation qualification, calibration and repair documentation.
  • Support new instrument qualifications and upgrades, be part of the team that will generate, review and approve the IOQ/PQ documentation (GxP, URS, IOQ, ERES, PQ, RTM, ATR, SOP/WI).

Qualifications & Experience:

  • A bachelor’s degree in Engineering, biological science or similar.
  • 3 years’ experience which should be related to instrument qualification experience in a GMP laboratory setting.
  • Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).
  • Strong experience with analytical instrument qualification and maintenance.
  • Excellent understanding of data integrity compliance requirements.
  • Ability to prioritize maintenance activities in line with the project schedules and business needs.
  • Ability to maintain the flexibility to react to changing business needs.
  • Metrology/Calibration experience advantageous.

To apply for this job email your details to orla.daly@tandempm.ie.