Key Job Responsibilities:
- Generate validation documentation (URS, IQ, OQ, PQ and process characterization studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerized systems
- Generate collection plans for the qualification and acceptance of incoming components including product sub-assemblies
- Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team
- Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerized systems to ensure the validation status of equipment is maintained
- Ensure validation documents are up-to-date (primarily project MVPs and key inputs)
- Manage the execution of the product/process validation as per the MVP and project plan
- Work directly with customer validation representatives to define inputs and requirements to the MVP
- Ensure all results and data are correct and follow-up on any gaps or discrepancies
- Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment
- Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions
- Maintain validation procedures and templates up to date, focusing on continuous improvement
- Degree in Science/Engineering with 3+ years’ experience in a similar role within the Medical Devices or related Healthcare industry.
- Strong knowledge of ISO and FDA quality requirements.
- Good understanding of validation concepts and documentation.
- Strong communication skills, including ability to advise and influence.
- Excellent attention to detail and report-writing ability
- Proven ability to work on own initiative.
- Highly organized with strong ability to prioritize tasks.
- A general knowledge and experience of statistical analysis methods is an advantage.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent