Quality Manager

  • Salary: Competitive
  • REF Number: 00048268
  • Consultant: Emily Mills
  • Contact: 01246 457730
  • Date Published: 22.05.2020
  • Sector: Pharmaceutical, Life Sciences
  • Location: Southampton, South East
  • Discipline: Quality/Regulatory

CK Technical are recruiting for a Quality Manager to join a biotechnology company on a permanent basis at their site in Southampton.

The Role: As a Quality Manager, you will be responsible for site specific aspects of the Quality Management System.

Your main duties as a Quality Manager will be to:

  • Manage the requirements for the quality and regulatory compliance for the design, manufacture, sale and global distribution of products.
  • Manage QA and QC team.
  • Support for regulatory and customer audits.
  • Provide quality and Regulatory support to the development and OEM project, including the generation, review and approval of process validation documentation.
  • Review and approval of technical, regulatory and QMS documentation.

Your Background:

  • At least five years' experience as Quality Manager in a diagnostic environment.
  • Fully conversant with the key regulations for in vitro diagnostic devices, IVDD, IVDR.
  • Experienced and conversant with current requirements for ISO 9001, ISO13485 and 21 CFR Part 820.
  • Qualified internal auditor.
  • Knowledge of molecular diagnostics, qPCR technology and applications.

Apply: For more information or to apply for this Quality Manager position, please contact CK Technical on 01246 457730 or email emills@cktechnical.co.uk, quoting job ref 48268.

It is essential that applicants hold entitlement to work in the UK.

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