Quality Technician

Manpower have an exciting opportunity for a Quality Technician with our Carlow based Life Sciences client.
Location- Carlow.
Position - Quality Technician.
Duration- 11 Month contract.
Shift- 4 cycle shift pattern.

Description:

• Provide Quality support to 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.

The Quality Technician role requirements:

• Work a 4-cycle shift pattern role
• Have 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
• Have Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES
• Fully understand 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
• Be involved in customer complaint investigation if required
• Support the annual product quality reviews if required.

Experience:

• 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.

Education

• Degree qualification or equivalent (Science, Engineering, Technical)
• Experience in Sterile Manufacturing