The Quality Assurance Specialist within Our Company is required to 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 c GMP, US and EU regulatory requirements Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and c GMP 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 RESPONSIBILITIES Provide Quality support to IPT production teams to ensure c GMP standards are maintained.Do not wait to apply after reading this description a high application volume is expected for this opportunity.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.
xsokbrcLiaise 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.