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QA Specialist

2 months ago


Sheffield, Sheffield, United Kingdom BioTalent Full time
Job Title: QA CSV Manager

BioTalent is seeking a highly skilled QA CSV Manager to join our team. As a QA CSV Manager, you will be responsible for ensuring the quality and integrity of our clinical research data.

Key Responsibilities:

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

Requirements:

  • 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

What We Offer:

  • A remote position with the flexibility to work from anywhere in the UK, Netherlands, or Belgium
  • A competitive salary and benefits package
  • The opportunity to work with a leading CRO and contribute to the success of our clinical research services