Job Description
We are seeking a Quality Assurance Specialist to join our team at a leading pharmaceutical company in Carlow. Job Duties: 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 Work well cross functionally and be an active team member POSITION RESPONSIBI...