Auditor - Gmp

CSL Seqirus

**
Gmp audit execution experience
21 cfr part 210/211 knowledge
Eudralex volume 4 understanding
** CSL Seqirus is seeking a GMP Auditor to join their Research & Development Quality audit program, focusing on ensuring compliance with scientific data accuracy and regulatory standards. The ideal candidate will possess relevant quality assurance experience in GMP-regulated environments, with strong audit expertise and communication skills. **

Job Summary

  • This role serves as a GMP Auditor responsible for executing the global audit plan to ensure the accuracy of scientific data and compliance with legal standards.
  • The position requires conducting assigned external audits of contract manufacturers and vendors while identifying non-compliance trends that could impact product supply reliability.
  • CSL Seqirus is one of the largest influenza vaccine providers in the world, offering a culture of inclusion and belonging at its core.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a GMP Auditor to join their Research & Development Quality audit program, focusing on ensuring compliance with scientific data accuracy and regulatory standards. The ideal candidate will possess relevant quality assurance experience in GMP-regulated environments, with strong audit expertise and communication skills. **

Skills & Requirements

Must-have

  • GMP audit execution experience
  • 21 CFR Part 210/211 knowledge
  • EudraLex Volume 4 understanding
  • CAPA development skills
  • Trend analysis capabilities

Nice-to-have

  • Collaborative stakeholder management
  • Multinational team navigation
  • Risk-based solution development
  • SOP improvement initiatives

Key Requirements

  • BS degree in biological science or related discipline
  • Quality Assurance experience in GMP-regulated environment
  • Audit and inspection management expertise
  • Up to 50% travel capability

Work Rights

Not specified

Tailored Resume

Cover Letter