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Job Description
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.
- 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.
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