We're currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties Competent in process validation requirements on new manufacturing processes, equipment introductions & process changes.Responsible for performing process validation (OQ & PQ) by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.Utilize six sigma statistical analysis and experimental design tools to characterize processes and support process validation activities.Write, execute, and review all validation documents.Defines the requirements for Process Validation in alignment with approved SOPs.Executes test plans according to approved procedures, tabulates test results, and organizes data packages.Compiles and analyses data, prepares reports and makes recommendations for changes and/or improvements.May also investigate and troubleshoot problems which occur and determine solutions.Coordinates and executes validation change control and preparation of protocols and reports.Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.Independently applies validation principles to work assignments, reviews and approves documents and resolves problems.Coordinates assigned projects and represents department on project teams.Resolves validation issues of moderate scope with limited direct supervision. Education & Experience Degree qualified in a relevant Engineering / Science discipline, with 5+ years relevant experience.Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.Six Sigma Black Belt certified is preferred.Experience in Statistical analysis & experimental design is essential. If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or ****** for further information.
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