Validation Quality Engineer
|Job Title:||Validation Quality Engineer|
|Duration:||3 month probation, rolling contract|
|Contact Name:||Brid Connolly|
Validation Quality Engineer role with our client in Galway. Working as part of the Quality Team, the post-holder will have overall responsibility for ensuring the on-going validation compliance of equipment, systems and processes.
Key Job Responsibilities:
- Management & Co-ordination of product / process validation activities with internal departments, external contractors, customers & suppliers per the MVP and project plans.
- Work directly with customer validation representatives to define inputs and requirements to the MVP.
- Generate validation documentation (MVP, DOE, IQ, OQ, PQ and process characterisation studies & validation reports)
- Maintain complete and accurate documentary evidence concerning Qualification and Validation exercises.
- Ensure consistency on validation/qualification approach across systems and projects.
- Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
- Ensure validation documents and templates are up-to-date, focusing on continuous improvement.
- Ensure all results and data are correct and follow-up on any gaps or discrepancies.
- Assist in the execution of protocols for new product introduction, product transfers, equipment, process, utilities, methods and computerised systems.
- Review, preparation & approval of deviations and change controls.
- Conduct equipment, process, and systems validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
- Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.
- Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
- Present validation systems at internal and external audits and support quality assurance programmes.
- Responsible for QMS implementation activities required for new product introduction / product transfers and support the Quality function with any additional assigned QMS activities.
- Degree in Science/Engineering with 5+ 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 with validation experience preferable.
- 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 including Minitab use.
- Experience in completing Gauge R&R Studies and evaluation / analysis.
- Experience of continuous improvement tools such as Lean Six Sigma (Green Belt qualified).
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