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 assigned external audits of contract manufacturers and vendors while identifying findings that could impact product supply reliability.
CSL Seqirus is part of CSL, 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 the accuracy of scientific data and compliance with legal standards.
Skills & Requirements
Must-have
GMP audit execution experience
External CMO vendor auditing
Risk categorization and CAPA development
Trend analysis for non-compliance
21 CFR Part 210/211 knowledge
EudraLex Volume 4 EU GMP Guidelines
Nice-to-have
Collaborative stakeholder engagement
Multinational team communication skills
SOP improvement initiatives
Strong analytical problem-solving
Ability to work with limited supervision
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment