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QC Instrumentation Systems Specialist

QC Instrumentation Systems Specialist - Pharma-Dublin-Contract.

The Quality Control Instrumentation Systems Specialist will be responsible for planning, executing, and managing the activities required to maintain the testing infrastructure of the QC lab. Strong CSV experience with analytical instrument qualification and computer systems implementation essential.

Overview of Main Responsibilities (full job description available on request):

  • Responsible for the 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.

  • Support the QC department for troubleshooting, investigations, and deviations as an SME.

  • Manage deviations, CAPA’s and change control’s 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.

What the ideal candidate looks like:

  • A bachelor’s degree in Engineering, biological science, or related field.

  • 3 years’ experience in CSV and/or CQV for laboratory systems and instrumentation.

  • Experience in regulatory audits.

  • Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).

  • Excellent understanding of data integrity compliance requirements.

  • Experience and understanding of the change management requirements of validated systems and software.

For a confidential discussion and more information on the role, please contact Aisling Lane.

(021) 4320675