Quality, Science, Pharmaceutical & Food

• 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 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 risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards
• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

• Bachelor’s Degree or higher preferred in a Science discipline

• 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
• Experience in SAP, MES, Trackwise desirable

• Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Knowledge of cGMP and GDP essential Report, standards, policy writing skills required
• Competent in the use of MES and SAP

PE Global