Quality Technician (24/7 Shift)

Summary:
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.

Responsibilities:

• 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.