QC Instrumentation Maintenance Specialist
RK21700
Contract – 11 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



The role of Quality Control (QC) Instrumentation Systems Specialist operates as part of a dynamic team to plan, execute, and managing the activities required to maintain the testing infrastructure of the QC lab. The team working s is one of collaboration, coaching, and teamwork to provide Quality oversight and expertise to the QC team to support a High Performing Organisation.



Duties:

• The QC Instrumentation Specialist roles and responsibilities include but are not limited to the following:
• Responsible 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.
• Assist with implementation of Quality Chapters to ensure we maintain best practices and build excellence into our QC systems and processes.
• Author and revise local SOPs, work instructions, and guidelines.
• Serve as an SME for regulatory and internal inspections and audits.
• Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.

• 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).