Director, Quality Systems Audit
Boehringer Ingelheim Shanghai Pharmaceuticals
Rory Budihandojo is the director of quality systems audit at Boehringer Ingelheim Shanghai Pharmaceuticals. He has more than 20 years of worldwide pharmaceutical experience (including Pfizer, GSK, Schering Plough) with responsibilities in R&D, manufacturing (API and finished dosage), QA, IT, pharmaceutical technology, and quality audit. He performed method, process, facility, utility, equipment, and computer validation, as well as GMP auditing of contract manufacturers, suppliers, and internal audits. He has validated chromatography, LIMS, PLC, SCADA, DCS, DMS, BAS, ERP, SAP, change-control systems, and more.
He was a member of PhRMA and PDA CSV Committee, and a founding member of GAMP Americas, and now serves as the vice-chairman and as a global GAMP Council member. He has published several articles in computer validation and was the lead author of PDA Technical Report No. 31. He serves on the editorial board of Pharmaceutical Technology, BioPharm International, Pharma Magazine, Pharm Tech Europe, and Pharmaceutical Engineering. He has a diploma in electronics, and degrees in chemistry and mathematics.