We are seeking an experienced Biologics Auditor to support client engagements across China. This role is responsible for conducting independent audits of biologics manufacturing sites, suppliers, and contract organizations to ensure compliance with international quality and regulatory standards.
Key Responsibilities:
- Plan, conduct, and report audits of biologics facilities, focusing on Drug Substance Manufacturing processes and associated critical control points.
- Evaluate compliance with relevant regulations and standards, including ICH Q7, ICH Q8–Q11, ICH Q12, WHO TRS guidelines, Chinese NMPA regulations, and FDA 21 CFR Parts 210/211, 600–680.
- Assess compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Laboratory Practice (GCLP) standards as they relate to biologics.
- Review quality management systems, batch records, raw material controls, environmental monitoring, aseptic processing, and validation activities.
- Communicate findings and provide recommendations for corrective and preventive actions (CAPA).