Quality Assurance Specialist
PROCHEM Engineering Limited
Carlow
Role Summary: A new opportunity has arisen for the role of a Quality Assurance Specialist at our client’s busy pharmaceutical site in Co. Carlow. This is a 4-cycle shift pattern role. Technical knowledge of sterile manufacturing processes required. The successful candidate will 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. Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance. Core Duties and Responsibilities 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. Support the spot check/walk-through process of the production lines. Be involved in customer complaint investigation if required. Support the annual product quality reviews if required. 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 the current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations. Foster a culture of continuous improvement by deploying site Six Sigma tools and support implementation of Model Area within operations from the start. Fully understand relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements. Minimum Qualifications and Experience: Degree qualification or equivalent (Science, Engineering, Technical. Experience in Sterile Manufacturing. Sterile filling processes and equipment and support services experience. Lean Six Sigma Methodology experience desired. Have Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES. 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. Focus on Customers and Patients. To Apply: If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us: 14 Danville Business Park, Kilkenny, Ireland. +353 56 77 90100. recruitment@prochem.ie. Click here to submit your CV. Please note, we do not require agency assistance with this role. .
875 days ago