18-year experience in leading and managing quality system, analytical and CMC supports for the pharmaceutical industries in US and over 30-year experience in Analytical Research KNOWLEDGE: ICH/FDA/EMEA/GMP regulations and guidance and IND/IMPD/CMC/NDA documents Regulatory Affairs Certified (RAC) by RAPS EXPERTISE: Managing internal and external analytical capacities, and establishing analytical quality system to support pharmaceutical developments and regulatory submissions
Establish and maintain GMP quality system; Set up GMP analytical lab and functions; Author SOPs, specifications, test methods, validation and stability protocols/reports Manage stability program, ScienTek Stability System; Customize and streamline Waters Empower Chromatographic System Power user of HPLC, UPLC, GC, Mass Spec and In vitro release testing.