QC Systems Specialist
RK23151
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 QC Systems Specialist leads continuous improvement of QC operations, through their QC Systems knowledge and areas of expertise.
Duties:
• Responsible for the maintenance of the QC systems and instrumentation, 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 QC systems and instrumentation and team priorities.
• 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.
Educational and Experience
• Third level education in a Science or Engineering related course of study
• 3+ years' experience, ideally in Quality or Technical Operations within the Biological and/or pharmaceutical industry.
• Strong experience with analytical instrument maintenance, CSV experience beneficial.
• Excellent understanding of data integrity compliance requirements.
• Experience and understanding of the change management requirements of validated systems and software.
• Experience in quality management systems such as Veeva, SAP, LIMs, Trackwise