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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Assurance Specialist (shift)


Reference:RK25863 Location: Carlow
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, QA Specialist

Quality Assurance Specialist (shift)
RK25863
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.



The Quality Specialist is a member of a team within Global Development Quality (GDQ) and is involved in supporting the GMP Quality Assurance activities for the GDQ IMP Licence.



Key Responsibilities:

  • 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
  • Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
  • Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.


Education and Experience:
  • Minimum qualification B.Sc. or M.Sc./ M.Eng Engineering or Science discipline
  • 2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
  • Knowledge of cGMP and GDP essential Report, standards, policy writing skills required
  • Competent in the use of MES, Trackwise and SAP



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