Pharmaceutical Engineer
APIC-certified ICH Q7 Auditor / ECA-certified QA Manager and Auditor

PROFESSIONAL BACKGROUND

 
Junnian holds a degree in Engineering in Pharmaceutical Technology from Zhejiang University of Technology. He accumulated over four years of hands-on experience as a Process Engineer at a leading Hangzhou-based pharmaceutical manufacturer, where he specialized in sterile formulation development and technology transfer, GMP-compliant process documentation, deviation management and CAPA implementation, GMP training program design for new and transferred personnel, etc. He joined our team in 2020.

 
AUDITING EXPERTISE

 
Junnian is an APIC-certified auditor of active pharmaceutical ingredients and a QA Manager and Auditor certified by the European Compliance Academy. His languages are English and Mandarin Chinese. He has performed hundreds of audits of pharmaceutical factories since 2020, mostly in China on behalf of European and American customers, including:

• Non-sterile APIs made by synthesis, fermentation, plant extraction, and animal tissue extraction
• Sterile APIs
• Sterile injections
• Formulated medicinal products
• Medical devices and primary packaging devices
• Fine chemicals and regulated starting materials