Location:
Carlow, Ireland - Onsite
This 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 contract
Our 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 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 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