Thao Lam

With over 15 years of experience in the pharmaceutical industry, I bring extensive expertise in Innovation & Development for new products and successful market launches. My specialization includes a diverse portfolio of pharmaceutical drugs and food supplements comprising first generics, differentials formulation development. Deeply experience in establishing and maintaining quality management system that adhere to the highest international standards and regulatory guidelines. I possess exceptional project management and leadership skills, combined with excellent multitasking abilities and a strong commitment to quality. • Manage team for new product innovation and development using QbD approach, technology transfer and registration for VN and APAC markets as per ACTD format. • Participate in Bioequivalence study, proactively collaborate with Contract Research Organization and Clinical department to ensure smooth execution. • Project management from new product ideation till Technology Transfer and launch included budgeting, time management, resource planning, build strategy, stakeholder management, risk calculation to get project approved then drive succeed of the project, with resulting to +100 products launched to the market. • Renovate pilot formulation lab included HVAC system, Compressed air and procure new equipment. Built a full wet granulation line from dispensing till packaging for oral solid dosage form (roller compactor, bi-layer tablet press, …), F/U/E qualification as well as computerized system validation (CSV), Calibration, Maintenance • Manage team to pass through several audits without any critical observation. Build and maintain a high-quality standard in R&D, experienced with QMS such as Root cause Analysis using 5W, 6M, Fishbone, FMEA; Audit and CAPA management, Supplier qualification, Change Control, Deviations system, … • Implement ERP (SAP S4/HANA) in I&D go-live within period of short time.