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...