Quality Associates

Pe Global

Cork

PE Global are currently recruiting for Quality Professionals for one of our clients in Cork. This is a one year contract directly with the client. Responsibilities of the role: Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. Support process investigations providing formal structured approach to identify root causes, establish corrective actions and execute prevention plans in products and/or processes. Employ appropriate risk management to prevent unanticipated failure modes and improve capability of processes. Ensures effective quality strategies are created for the validation of equipment, test methods and processes as well as master validation plans and risk management documentation inaccordance with regulatory requirements and internal requirements. Provides guidance on the preparation and execution of computer software validation protocols, test scripts and reports to ensure all Computer System Validation (CSV) requirements are met. Reviews analytical methods and specifications, validation protocols, deviations, investigations, impact assessments and other forms of Quality documentation as assigned. Provide quality input and support to the manufacturing area and participate in key initiatives and projects. Drive preparation and actively participate in external audits by Notified Bodies and Health Authorities, where necessary. Education and Experience required: Degree in Science, Engineering or a relevant discipline. 5 years experience within a Quality background. Knowledge of FDA, medical device, GMP and validation requirements. Experience in equipment and process validations. If you are interested in this position, please forward your CV tocatherine.osullivan@peglobal.netor call Catherine on 0214297900. This job originally appeared on RecruitIreland.com.

2319 days ago