Quality Systems Specialist
CK Science are currently recruiting for a Quality Systems Specialist, with an industry background in conducting internal and supplier audits, to join a global Biotechnology company based in Bedford on a permanent basis.
The Benefits: On offer isa competitive salary plus benefits (pension, life assurance and 25 days holiday plus bank holidays).
- Responsible for creating and maintaining Quality System policies, processes and documentation within the Division as per ISO, FDA,and other regulatory agencies. The client will allow for remote working, however would require onsite presence when required.
Other responsibilities will include to:
- Design and deliver training of quality system processes
- Act as the key Quality liaison to departments operating within the QMS, such as Marketing and IT
- Be part of the Internal Auditor and Supplier Auditor team
- Partake as required in any Customer audit and other such inspections
- Support other QMS activities as required by the Quality Manager
Your Background: Essential Skills:
- Degree qualified in science or a related field.
- 5 years+ regulated industry experience and regulatory understanding i.e. ISO9001, ISO13485, ISO14971, FDA 21 CFR part 820, 21 CFR 803 and FDA 21 CFR part 11.
- Experienced as Quality Systems Specialist or equivalent role
- Strong background in developing and maintaining quality system processes
- Knowledge in conducting internal and supplier audits
- Certified ISO13485 Internal Auditor
- Experience using an Electronic Document Management System
- Certified Lead Auditor
- Process Excellence certified (Green Belt / Black belt).
- Experience of managing an internal customer relationship- Conversant in an East Asian or Continental Europe language at a business level proficiency
Entitlement to work in the UK is essential. For more information or to apply for this position, please contact Naynesh Mistry on 01246 457703 or email email@example.com. Please quote reference 49728 in all correspondence.