This role serves as a GMP Auditor responsible for executing the global audit plan to ensure scientific data accuracy and regulatory compliance
Job Summary
This role serves as a GMP Auditor responsible for executing the global audit plan to ensure scientific data accuracy and regulatory compliance.
The position requires conducting audits of external contract manufacturers and internal facilities while identifying non-compliance trends that could impact product supply reliability.
CSL Seqirus is part of CSL, one of the largest influenza vaccine providers globally with 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 scientific data accuracy and regulatory compliance.
Skills & Requirements
Must-have
GMP audit execution experience
21 CFR Part 210/211 knowledge
EudraLex Volume 4 familiarity
CAPA development skills
Trend analysis capabilities
Nice-to-have
Collaborative stakeholder engagement
Multinational team navigation
Risk-based solution development
SOP improvement initiatives
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment
Experience in audit and inspection management
Working knowledge of 21 CFR Part 600 and ISO 13485