Our client is a biopharmaceutical company based in Carlow, looking for a Quality Technician to provide quality support to operations production teams to ensure cGMP standards are maintained.
- Generate reports highlighting and assisting 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 e.g. 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.
- Perform timely reviews on batch documentation (EBRs) / 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.
Qualifications & Experience:
- Degree qualification or equivalent (Science, Engineering, Technical).
- Experience in Sterile Manufacturing, sterile filling processes and equipment and support services.
- Lean Six Sigma Methodology experience desired.
- Technical knowledge of sterile manufacturing processes.
To apply for this job email your details to firstname.lastname@example.org.