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Specialist, Quality Assurance GCP

Bologna, IT +2 more…Posted 2 weeks ago

Job Description

  • Minimum 4–6 years of experience in Clinical Quality Assurance, Clinical Operations, or related GxP functions.
  • Hands on experience supporting Phase II–IV clinical trials.
  • Experience working with CROs and external vendors.
  • Exposure to regulatory inspections or Sponsor audits is preferred.
  • Good knowledge of ICH GCP guidelines and applicable global clinical trial regulations.
  • Understanding of sponsor responsibilities in outsourced clinical trial models.
  • Familiarity with quality systems, audit processes, and CAPA management.
  • Ability to apply a risk-based approach to quality oversight.
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