Auditor - Gmp

csl.co.th

Not specified (considering the job involves up to 50% travel, it may lean towards hybrid or on-site).
Gmp audit execution experience
Contract manufacturer auditing skills
Capa development and risk categorization
CSL Seqirus is seeking a GMP Auditor to join their Research & Development Quality audit program, responsible for executing audits to ensure compliance with scientific data accuracy and regulatory standards. The ideal candidate should have experience in quality assurance within GMP-regulated environments, strong auditing skills, and the ability to collaborate effectively with stakeholders

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 requires conducting audits of external contract manufacturers and internal facilities while identifying findings that could impact product supply reliability.
  • CSL Seqirus offers a culture of inclusion and belonging, fostering innovation through a diverse workforce dedicated to pandemic preparedness.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a GMP Auditor to join their Research & Development Quality audit program, responsible for executing audits to ensure compliance with scientific data accuracy and regulatory standards. The ideal candidate should have experience in quality assurance within GMP-regulated environments, strong auditing skills, and the ability to collaborate effectively with stakeholders.

Skills & Requirements

Must-have

  • GMP audit execution experience
  • Contract manufacturer auditing skills
  • CAPA development and risk categorization
  • 21 CFR Part 210/211 knowledge
  • EudraLex Volume 4 EU GMP guidelines

Nice-to-have

  • Strong negotiation and interpersonal skills
  • Ability to work with multinational teams
  • Experience with ISO 13485 standards
  • Trend analysis in non-compliance areas

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 availability

Work Rights

Not specified

Tailored Resume

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