Summary
Renhuan Huang is a Quality Control leader with over 15 years’ hands-on experience managing QC laboratories and quality systems for sterile drug substances and products under FDA, EMA and CFDA regulations. He combines deep technical expertise in analytical chemistry, microbiology and sterile assurance with strong computerized system validation and project management skills, having led CSV, LIMS, TrackWise and SAP implementations. Renhuan has extensive regulatory audit experience and a proven track record in method validation/transfer, OOS investigations, instrument qualification and parametric release for parenterals and mAbs. A certified Lean/Green Belt and qualified GMP auditor, he also brings practical CMC documentation review experience across radiopharmaceuticals and contrast media. Fluent in English and based in Shanghai, he uniquely blends data-science-oriented Python work in analytical chemistry with pragmatic GMP operations to improve quality and throughput.
9 years of coding experience
2 years of employment as a software developer
Bachelor’s Degree Chemistry, Bachelor’s Degree Chemistry at Fudan University
English, Shanghainese