QA Operations Technician (Shift)

Website Ref : TPM04469

Summary:
A QA Operations Technician is required for a biopharmaceutical company in Carlow. The successful candidate will work in a 4 shift pattern role.

Responsibilities:

  • 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.
  • Support the annual product quality reviews if required.
  • Provide Quality support to operations 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, manages multiple tasks, and meet deadlines.
  • Performs 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 MSD Six Sigma tools and support implementation of Model Area within operations from the start.

    Qualifications & Experience:

  • Degree qualification or equivalent (Science, Engineering, Technical).
  • Experience in Sterile Manufacturing.
  • Sterile filling processes and equipment and support services experience.
  • Lean Six Sigma Methodology experience desired.
  • Ability to learn and utilize computerized systems for daily performance of tasks.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.