Auditor - Gcp

Csmmh

Clinical quality assurance experience
Gcp regulatory knowledge ich e6
External audit execution skills
This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data

Job Summary

  • This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data.
  • The position requires identifying non-compliance trends and communicating findings to line management to ensure trial robustness.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies.

Matching Summary

This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data.

Skills & Requirements

Must-have

  • Clinical Quality Assurance experience
  • GCP regulatory knowledge ICH E6
  • External audit execution skills
  • Risk categorization and CAPA development
  • Global travel capability up to 50%

Nice-to-have

  • Strong negotiation and interpersonal skills
  • Experience with multinational clinical teams
  • Ability to work with limited supervision
  • Collaborative approach to systemic stability

Key Requirements

  • BS degree in biological science or related discipline
  • Quality Assurance experience within GCP-regulated environment
  • Experience in clinical audit and inspection management

Work Rights

Not specified

Tailored Resume

Cover Letter