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QA CSV Manager

2 months ago

United Kingdom BioTalent Full time

BioTalent has teamed up with a CRO focussed on providing clinical research services who are on their search for a QA CSV Specialist/Manager. You will be responsible computer system validation activities, ensuring compliance with FDA, EMA, GAMP 5, and internal policies.


This is a Remote position, however you must be based in either The United Kingdom, The Netherlands, or Belgium.


You will be responsible for:

  • Providing expert guidance on Good Clinical Practice to ensure quality, data integrity, and safety across all our services
  • Reviewing lifecycle validation documentation and system changes
  • Drive validation project completion, support computerised systems investigations, and participate in internal and external audits
  • Management of qualification, changes, and deviations across systems using advanced Quality Management Systems such as Veeva, MasterControl, and Trackwise


You will bring the following:

  • A degree in Life Sciences, Engineering, or Computer Science
  • Experience in a QA position, specialising in CSV / IT
  • Solid experience in a GxP environment
  • Experience working with QMS e.g. Veeva, TrackWise, MasterControl