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 assigned external audits of contract manufacturers, vendors, and suppliers while identifying non-compliance trends that could impact product supply reliability.
CSL Seqirus offers a culture of inclusion and belonging where diverse workforces are celebrated to foster innovation and better connect with patients globally.
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
Risk categorization and CAPA development
21 CFR Part 210/211 knowledge
EudraLex Volume 4 EU GMP Guidelines
50% travel requirement
Nice-to-have
Collaborative stakeholder engagement
Systemic risk trend analysis
Multinational team communication skills
SOP improvement initiatives
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GMP-regulated environment
Audit and inspection management expertise
Working knowledge of ISO 13485 and FDA regulations