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 involves conducting assigned external audits of contract manufacturers, vendors, and suppliers while identifying findings and non-compliance trends that could impact product supply reliability.
CSL Seqirus is one of the largest influenza vaccine providers in the world, utilizing state-of-the-art production facilities in 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 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
Nice-to-have
Strong negotiation skills with stakeholders
Experience with ISO 13485 standards
Ability to work with multinational teams
Trend analysis for non-compliance risks
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience within GMP-regulated environment