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 and corporate 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 and corporate standards.
The position requires conducting assigned external audits of contract manufacturers and vendors while identifying non-compliance trends that could impact product supply reliability.
CSL Seqirus is part of CSL, one of the largest influenza vaccine providers in the world, offering a culture focused on inclusion, belonging, and innovation.
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 and corporate standards.
Skills & Requirements
Must-have
GMP audit execution experience
External CMO vendor auditing
CAPA development and risk categorization
21 CFR Part 210/211 knowledge
EudraLex Volume 4 EU GMP guidelines
50% travel requirement
Nice-to-have
Strong negotiation skills with stakeholders
Experience with ISO 13485 standards
Ability to work with limited supervision
Collaborative approach to corrective actions
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment