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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Assurance Specialist


Reference:RK26346 Location: Carlow
Qualification:DegreeExperience:1-2 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Quality Assurance Specialist
Shift 4 cycle
RK26346
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.



Key Responsibilities:

  • Work a 4 shift pattern role
  • Technical knowledge of sterile manufacturing processes
  • 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
  • Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
  • Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
  • Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
  • Support the spot check/walk-through process of the production lines
  • Involved in customer complaint investigation if required
  • Work well cross functionally and be an active team member


Education and Experience:
  • Bachelor’s Degree or higher preferred in a Science discipline
  • 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
  • Experience in SAP, MES, Trackwise
  • Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Knowledge of cGMP and GDP essential Report, standards, policy writing skills required

If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.