[Urgent Search] Quality Assurance Specialist
1 week ago
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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