Job Description

Job Title: GCP Auditor/Senior Auditor, Quality AssuranceJob Description

This position focuses on ensuring GXP compliance with regulatory authorities, driving and implementing compliance directives, and supporting quality management systems to minimize risks in a regulated pharmaceutical environment. The role involves conducting and participating in all GXP QA audit programs, including internal and external audits, and providing support to the GXP QA Director across clinical operations, non-clinical, and manufacturing sectors.

Responsibilities
  • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
  • Plan and conduct audits of specific clinical processes based on risk.
  • Perform clinical vendor audits along with various subject matter experts to comprehensively assess all services provided by a vendor.
  • Develop audit reports and distribute them to appropriate stakeholders.
  • Own and m...
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