19332-QA Technician-Carlow Contractor

Responsibilities

• Work a 4 shift pattern role (33.33% shift rate)

• 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 IPT 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 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.

Requirements

• 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