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, vendors, and suppliers while occasionally performing internal self-inspections.
CSL Seqirus is 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
Contract manufacturer (CMO) auditing
CAPA development and risk categorization
21 CFR Part 210/211 knowledge
EudraLex Volume 4 EU GMP Guidelines
50% travel requirement
Nice-to-have
Collaborative stakeholder engagement
Systemic non-compliance trend analysis
Multinational team communication skills
SOP improvement initiatives
ISO 13485 familiarity
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment