Auditor - Gmp

Seqirus

Conduct external gmp audits of cmos
Develop comprehensive audit reports
Identify non-compliance trends
This role serves as a GMP Auditor responsible for executing the global audit plan to ensure scientific data accuracy and regulatory compliance

Job Summary

  • This role serves as a GMP Auditor responsible for executing the global audit plan to ensure scientific data accuracy and regulatory compliance.
  • The position involves conducting audits of external partners and internal facilities to identify findings that could impact product supply reliability.
  • CSL Seqirus is one of the largest influenza vaccine providers in the world, offering state-of-the-art production facilities across the U.S., U.K., and Australia.

Matching Summary

This role serves as a GMP Auditor responsible for executing the global audit plan to ensure scientific data accuracy and regulatory compliance.

Skills & Requirements

Must-have

  • Conduct external GMP audits of CMOs
  • Develop comprehensive audit reports
  • Identify non-compliance trends
  • Maintain knowledge of global GMP regulations
  • Manage corrective and preventive actions

Nice-to-have

  • Excellent interpersonal negotiation skills
  • Work effectively with multinational teams
  • Strong analytical problem-solving abilities
  • Support continuous improvement initiatives
  • Navigate manufacturing environments collaboratively

Key Requirements

  • BS degree in biological science or related discipline
  • Quality Assurance experience in GMP-regulated environment
  • Experience in audit and inspection management
  • Working knowledge of 21 CFR Part 210/211
  • Up to 50% travel capability

Work Rights

Not specified

Tailored Resume

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