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Validation Specialist
2 weeks ago
We are seeking a highly skilled and experienced Medical Device Validation Specialist to join our team. As a key member of our team, you will be responsible for ensuring the quality and safety of our medical devices.
Your primary focus will be on validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
You will be coordinating and directing active participation in the validation process, generation/maintenance/execution of Site Validation Master Plans, Project Validation Plans and schedules, validation protocols and final reports, as well as managing validation, exception event, and change control processes.
A successful candidate should have a degree in engineering or scientific discipline, 3 years plus of experience in validation/Quality in medical device plastics processing, moulding or assembly operations, and 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry.
This is an excellent opportunity for someone who enjoys working with a diverse team on interesting projects and wants to work with a globally recognised manufacturing site.
What We Offer- Attractive rate on offer
- Potential for career development