Overview
Location: Carlow, Ireland - Onsite
Shift position: 4 cycle 12 hours per shift. Example schedule: 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: Wednesday and Thurs Nights. Shift premium is 33%.
Type of contract: 11-month fixed term contract
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 operations
What 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 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 require
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