Location
remote
Job Type
Full-time
Posted
May 23, 2026
Job Description
An EU-based biotech company is seeking a freelance EU Qualified Person to act as Lead Auditor for an on-site GMP audit of a biologics CDMO in Shanghai, China .
- Engagement: Fractional
- On-site audit: 5 days (including travel & Audit)
- Location: Shanghai, China (travel required for select dates)
Scope
- On-site EU GMP audit in line with EudraLex Volume 4 , including Annex 1 and Annex 2
- Review of biologics manufacturing, QC, warehousing, utilities, and quality systems
- Assessment of suitability for EU packaging, labelling, and release
- Preparation of a GMP audit report suitable for EU QP reliance , including CAPA follow-up
Requirements
- Certified EU Qualified Person (Directive 2001/83/EC, Art. 49)
- Strong biologics / bioprocessing background
- Prior experience aud...