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 trouble-shoot 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 [email protected] for further information.
