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 involves conducting audits of external contract manufacturers and internal facilities to identify non-compliance trends that could impact product supply reliability.
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
21 CFR Part 210/211 knowledge
EudraLex Volume 4 familiarity
CAPA development skills
Risk categorization expertise
Nice-to-have
Strong negotiation skills
Multinational team collaboration
ISO 13485 awareness
Systemic risk identification
SOP improvement initiatives
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment