The Role:

6 month contract working as part of the Quality Team, the post-holder will have 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.

Skill Requirements:

• Degree in Science/Engineering with 2+ years’ experience in a similar role within the Medical Devices or related Healthcare industry.
• Good knowledge of ISO and FDA quality requirements.
• 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).