Auditor - Gmp

CSL Seqirus

Not specified; not specified; not specified
Not specified
Gmp audit execution experience
Contract manufacturer (cmo) auditing
Capa development and risk categorization
CSL Seqirus is seeking a GMP Auditor to join their Research & Development Quality audit program, responsible for conducting audits, assessing compliance, and identifying trends in non-compliance. The ideal candidate should possess a strong background in quality assurance within GMP-regulated environments and excellent 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 audits of external contract manufacturers and internal facilities to identify findings that could impact product supply reliability.
  • CSL Seqirus offers a culture of inclusion and belonging where diverse workforces are sustained to move the company and industry into the future.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a GMP Auditor to join their Research & Development Quality audit program, responsible for conducting audits, assessing compliance, and identifying trends in non-compliance. The ideal candidate should possess a strong background in quality assurance within GMP-regulated environments and excellent communication skills.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • GMP audit execution experience
  • Contract manufacturer (CMO) auditing
  • CAPA development and risk categorization
  • 21 CFR Part 210/211 knowledge
  • Trend analysis for non-compliance

Nice-to-have

  • Collaborative stakeholder engagement
  • Multinational team interaction
  • SOP improvement initiatives
  • EudraLex Volume 4 familiarity

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 Parts 210/211, 600, 820
  • Ability to travel up to 50%

Work Rights

Not specified

Tailored Resume

Cover Letter