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Quality Assurance Specialist (Shift)

Quality Assurance Specialist (Shift)

ScientificjobsCarlow
23 days ago
Job description

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 Manufacturing
  • Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
  • Sterile filling processes and equipment and support services experience
  • Lean Six Sigma Methodology experience desired
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    Quality Assurance Specialist • Carlow