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:
1. Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
2. Understanding of sterile manufacturing operations is preferred.
3. Ability to learn and utilize computerized systems for daily performance of tasks.
4. Ability to prioritize, manage multiple tasks, and meet deadlines.
5. 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
6. Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
7. Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.
8. Foster a culture of continuous improvement by deploying Six Sigma tools and support implementation of Model Area within operations from the start.
9. Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
10. Respond quickly to unplanned events, technical issues
Educational and Experience
11. Degree qualification (Science/Quality/Technical).
12. 2+ years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
13. Experience in Sterile Manufacturing
14. Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
15. Sterile filling processes and equipment and support services experience
16. Lean Six Sigma Methodology experience desired
If interested in this posting please feel free to contact Angela McCauley at Life Science Recruitment for further information.