Location:Carlow, Ireland - OnsiteThis is a shift position– 4 cycle 12 hours per shift e.g - Week 1- long week: Monday – Tuesday Days, Friday, Sat, Sun nights - Week 2- short week: Wed and Thurs Days, - Week 3:Long week: Monday – Tuesday nights, Friday, Sat and Sun Days - Week 4: short week: Wednes and Thurs Nights Shift premium is 33%Type of contract:11-month fixed term contractOur client:A global healthcare company committed to advancing medical innovation and improving patient outcomes through science-led initiatives.Key Responsibilities:• Provide quality support to IPT production teams to ensure cGMP standards are maintained• Demonstrate understanding of sterile manufacturing operations• Learn and utilize computerized systems for daily performance of tasks• Prioritize, manage multiple tasks, and meet deadlines effectively• Perform timely reviews on batch documentation (EBRs), line clearances, and assist in the resolution of concerns commensurate with the risk• Liaise with other department representatives to promote improvements in GMP and quality standards• Comply with current Manufacturing Division, Quality, and EHS Management System requirements relevant to commercial operationsWhat skills you will need:• Work a 4 shift pattern role• 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 require