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 audits of external contract manufacturers and internal facilities to identify findings that could impact product supply reliability.
CSL Seqirus is a major contributor to influenza vaccine prevention 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 the accuracy of scientific data and compliance with legal standards.
Skills & Requirements
Must-have
GMP audit execution experience
Contract manufacturer (CMO) auditing
21 CFR Part 210/211 knowledge
CAPA development and risk categorization
Trend analysis for non-compliance
Nice-to-have
Collaborative stakeholder engagement
Multinational team navigation
SOP improvement initiatives
EudraLex Volume 4 familiarity
ISO 13485 understanding
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment