Quality Systems Specialist

Job Overview


I am currently working with a well-established, global biotechnology company in the Midlands who are looking for a Quality Systems Specialist to join their team.

As Quality Systems Specialist you will ensure that the quality system is appropriate to the needs of the site and that it is implemented, and compliant to the various standards to which the sites operate.


  • Design and continuous improvement of the quality functions, including internal audits, supplier quality management, change control, documentation control, deviations, quality of data, QA batch release and electronic systems.
  • Develops and leads the inspection readiness program and hosts external inspections
  • Ensure the Quality Team are trained adequately to ensure all functions are resourced adequately.
  • Develop and Maintain Quality System metrics ensuring regular reporting of metrics to management
  • Responsible for the compliance of the quality system to various standards and directives e.g. cGMP


  • Degree level qualification in a science discipline
  • Certification in Quality Systems Management and/or auditing or similar
  • At least 5 years within a QA role, preferably with 1 of those in a lead capacity
  • Good knowledge of standards and regulations EU and FDA regulations
  • Internal auditing certification and experience in GMP auditing
  • Solid experience in hosting external audits

If this Quality Systems Specialist Job looks like it could be the next step in your Biotechnology career, please get in touch ASAP!!

Skills: GMP, Quality Systems ,Quality Assurance

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