QC Systems Specialist
Onsite
RK26190
Contract 12 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 supports the QC Laboratory through routine maintenance, troubleshooting and repairs of all analytical laboratory instruments, in addition to supporting the instrument lifecycle (installation, qualification, operation, and retirement).
Additionally, the QC Systems Specialist supports the management of software application such as Empower, LabX and Signals, and any requests relating to these systems.



Key Responsibilities:

• Responsible for the planned and unplanned 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.
• Serve as site co-ordinator for software applications such as Empower, LabX and Signals.
• Support the QC department as a Super User and complete method requests as required.
• 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.

• Third level education in a Science or Engineering related course
• 3+ years of related experience in the biopharmaceutical or pharmaceutical industry
• Strong experience with analytical instrument maintenance, CSV experience beneficial.
• Experience using software applications such as Empower.
• Excellent understanding of data integrity compliance requirements.