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
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 diversity fuels innovation and connects stakeholders to patients globally.
Matching 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.
Skills & Requirements
Must-have
GMP audit execution experience
Contract manufacturer (CMO) auditing
21 CFR Part 210/211 knowledge
EudraLex Volume 4 EU GMP guidelines
CAPA development and risk categorization
Nice-to-have
Strong negotiation skills with suppliers
Experience with multinational teams
Ability to work with limited supervision
Trend analysis for non-compliance
Collaborative problem-solving approach
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment