Auditor - Cqa

CSL Seqirus

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Clinical quality assurance experience
Gcp regulations knowledge ich e6
External audit execution skills
** CSL Seqirus is seeking an experienced CQA Auditor to execute a global audit plan within their Research & Development Quality audit program. The role requires conducting audits of clinical trial data and processes while ensuring compliance with regulatory standards and promoting continuous improvement. **

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 systematic risks within the Clinical discipline to ensure trial robustness.
  • CSL Seqirus is part of CSL, one of the largest influenza vaccine providers in the world with state-of-the-art production facilities.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking an experienced CQA Auditor to execute a global audit plan within their Research & Development Quality audit program. The role requires conducting audits of clinical trial data and processes while ensuring compliance with regulatory standards and promoting continuous improvement. **

Skills & Requirements

Must-have

  • Clinical Quality Assurance experience
  • GCP regulations knowledge ICH E6
  • External audit execution skills
  • CAPA development and reporting
  • Risk-based trend analysis

Nice-to-have

  • Collaborative stakeholder management
  • Global travel capability up to 50%
  • SOP improvement initiatives
  • Multinational team communication

Key Requirements

  • BS degree in biological science or related discipline
  • Quality Assurance experience in GCP-regulated environment
  • Experience in clinical audit and inspection management
  • Ability to manage schedule with up to 50% global travel

Work Rights

Not specified

Tailored Resume

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