Quality Technician

Quality Technician - QA IPT
AMC20833

Contract – 11 months
Shift role (4 cycle shift - 33% premium)
On site - Carlow

We’re currently recruiting for an exciting opportunity with a multinational Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational at an exciting growth period.

Requirements

• Third Level Degree qualified in a Science/Technical or related discipline.
• Experience in sterile manufacturing environment
• Lean six sigma methodology experience desired

• 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 IPT production teams to ensure cGMP standards are maintained.
• 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.