The Quality Assurance Specialist is required for an initial 11 month contract. 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 e.g. 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 Support the annual product quality reviews if required POSITION RESPONSIBILITIES Provide Quality support to 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 Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations. Foster a culture of continuous improvement by deploying Six Sigma tools and support implementation of Model Area within operations from the start. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS Technical Sterile filling processes and equipment and support services experience Lean Six Sigma Methodology experience desired Education Degree qualification or equivalent (Science, Engineering, Technical) Experience in Sterile Manufacturing General Good organizational skills and attention to detail Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally. Ability to learn and utilize computerized systems for daily performance of tasks. Strong influencing skills Demonstrable analytical and systematic problem-solving skills Skills: Quality Assurance batch documentation Investigations