Auditor - Cqa

CSL Seqirus

Not specified (assumed hybrid due to global travel requirement)
Clinical quality assurance experience
Gcp regulatory knowledge ich e6
External audit execution skills
CSL Seqirus is seeking a CQA Auditor to execute their global audit plan, focusing on ensuring compliance and data integrity in clinical trials. The ideal candidate will have experience in quality assurance within GCP-regulated environments and be capable of conducting audits and developing corrective actions

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 findings and non-compliance trends that could impact the integrity of clinical research across various stakeholders.
  • CSL Seqirus is a major contributor to influenza vaccine prevention with state-of-the-art facilities in the U.S., U.K., and Australia.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a CQA Auditor to execute their global audit plan, focusing on ensuring compliance and data integrity in clinical trials. The ideal candidate will have experience in quality assurance within GCP-regulated environments and be capable of conducting audits and developing corrective actions.

Skills & Requirements

Must-have

  • Clinical Quality Assurance experience
  • GCP regulatory knowledge ICH E6
  • External audit execution skills
  • Risk categorization and CAPA development
  • Trend analysis for non-compliance

Nice-to-have

  • Collaborative stakeholder engagement
  • Global travel capability up to 50%
  • Strong analytical problem-solving skills
  • Multinational team communication

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