QC Instrumentation Specialist

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.