Quality Assurance Specialist (Shift)
AM23281
Contract – 11 months
Carlow
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. 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.
Duties :
- Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
- Understanding of sterile manufacturing operations is preferred.
- Ability to learn and utilize computerized systems for daily performance of tasks.
- Ability to prioritize, manage multiple tasks, and meet deadlines.
- Perform timely reviews on batch documentation ( EBR’s ) / line clearances / assist in the resolution of concerns commensurate with the risk.Liaise with other Department representatives to promote improvements in GMP and Quality standards
- Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
- Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.
- Foster a culture of continuous improvement by deploying Six Sigma tools and support implementation of Model Area within operations from the start.
- Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
- Respond quickly to unplanned events, technical issues
Educational and Experience
Degree qualification (Science / Quality / Technical).2+ years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and / or pharmaceutical industry.Experience in Sterile ManufacturingOperational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MESSterile filling processes and equipment and support services experienceLean Six Sigma Methodology experience desired