David Suh

Background

About David Suh

Dedicated pharma quality manager with over 20 years of experience, determined to continually drive improvements in quality systems. Proven track record of completing projects on time, and working together in a team environment to take on new and complex projects. Current responsibilities include: Laboratory Investigations, Exception Reports, Risk Management, Review of Standalone Instrument Audit Trails, Notification to Management, Quarterly Management Review, and Audit Response Activity. Current DEA Site Coordinator for Lake Forest H3 R&D, preparing DEA-related documents and coordinating site activity. Specialties: DEA Site Coordinator, R&D Laboratory Investigation activity, GEMS TrackWise System, GxP Instrument Qualification, BET/Sterility Test Method Validations, and Test Method Transfer: Developed new USP Heparin Anti-Factor IIa Method for Global Stability Operations. Wrote, performed, and summarized transfer of method. Transferred the APTT Heparin Method in conjunction with the ACL Coagulation System to Global Stability Operations. Coordinated, performed, and finalized Bacterial Entotoxin Product Transfer Validations from Mayne Pharmaceuticals to Hospira after the acquisition.