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QA Specialist

Fantastic opportunity for a QA Specialist is a world class Biologics manufacturing facility. 

This is a 4 cycle shift role (33% allowance) sterile manufacturing processes


Duties and Responsibilities: 

  • 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 

  • 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

  • Support the annual product quality reviews if required

  • 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.


Candidate Requirements:

  • Degree in related area

  • Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES

  • Understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements

  • strong experience in pharmaceutical manufacturing (ideally sterile manufacturing)


For a confidential discussion and more information on the role, please contact Rory Walsh.

Rory Walsh

087 126956