Senior QA Specialist

  • Salary: Competitive
  • REF Number: 00051574
  • Consultant: Phoebe Walker
  • Contact: 01246 457737
  • Date Published: 03.09.2021
  • Sector: Medical Devices, Life Sciences, Diagnostics
  • Location: Eastleigh, South East
  • Discipline: Quality/Regulatory

CK Group are recruiting for a Senior QA Specialist to join a biotechnology group at their site based in Southampton on a 6 month contract basis.

Salary: Competitive.

Senior QA Specialist Role: Your main duties will be to ensure that all activities on site are in compliance with current ISO13485 and ISO9001 in accordance with company policies to meet business requirements

Duties will include:

  • To ensure continued compliance of the QMS to ISO13485 and ISO9001, concerning all areas of the product life cycle from product development to discontinuation
  • Supporting the maintenance, administration and execution of the change control, observations and non-conformances systems through the use of Entropy
  • To use professional judgment in all areas of the role to make the appropriate quality decisions and to initiate and promote quality improvements to prevent reoccurrence.

Your Background: The ideal candidate for this role will have:

  • Bachelor’s degree in Life Science.• Knowledge of qPCR, desirable
  • Written and verbal communication skills
  • Analytical problem- solving abilities.
  • Knowledge and experience of equipment software and process validation
  • Awareness of regulatory requirements. IVDD/IVDR

Apply: Entitlement to work in the UK is essential. For more information or to apply for this Senior QA Specialist position, please contact Phoebe Walker on 01246 457730 or email pwalker@ckgroup.co.uk. Please quote reference 51574.

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