Auditor - Cqa

cslseqirus.co.nz

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Clinical quality assurance experience
Gcp regulatory knowledge ich e6
External audit execution capability
** CSL Seqirus is seeking an experienced Auditor for their Research & Development Quality audit program, focusing on ensuring compliance with clinical trial data and regulatory standards. The role involves conducting audits, reporting findings, and collaborating with stakeholders to enhance clinical trial management processes. **

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 maintain trial robustness.
  • CSL Seqirus is a major contributor to influenza prevention globally with state-of-the-art production facilities in the U.S., U.K., and Australia.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking an experienced Auditor for their Research & Development Quality audit program, focusing on ensuring compliance with clinical trial data and regulatory standards. The role involves conducting audits, reporting findings, and collaborating with stakeholders to enhance clinical trial management processes. **

Skills & Requirements

Must-have

  • Clinical Quality Assurance experience
  • GCP regulatory knowledge ICH E6
  • External audit execution capability
  • CAPA development and risk analysis
  • 50% global travel requirement

Nice-to-have

  • Excellent negotiation skills
  • Collaborative stakeholder management
  • Systemic stability focus
  • Multinational team interaction

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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