Responsibilities
* 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
* Work well cross functionally and be an active team member
* 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.
Requirements
* 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
The position is onsite
This is a shift position - 4 cycle 12 hours per shift
* Week 1- Monday and Tuesday Days, Friday, Saturday, Sunday nights
* Week 2- Wednesday and Thurs Days,
* Week 3:: Monday and Tuesday nights, Friday, Saturday and Sunday days
* Week 4: Wednesday and Thursday nights