Richard Hsu

- 细胞建库及DS蛋白原液生产现场质量保证。 Quality Assurance of Cell Banking and Drug Substances(DS) Production. - 客户、NMPA、EMA、FDA审计、供应商审计等内外部审计等。 Client audit, NMPA, EMA, FDA inspection, self-inspection(internal audit), supplier audit, etc.

- Imported product quality management, including product release, deviation and complaint, etc. - Employee Training; - Supplier audit, self-inspection; - Ensuring the implementation of CFDA, EU and the corporate's regulations and procedures; ......

1. Commisioning and qualification of equipments & systems, validation, CSV (Computerized System Validation), familiar with URS/FS/RCL/RTM/DQ / FAT/SAT/ IQ / OQ / PQ, etc; - Commissionining & qualification of utilities and equipments, such as purified water system and HVAC SAT/IQ/OQ/PQ,etc; - Performing computerized system validation and periodic review as per ISPE GAMP5 guides and China GMP requirements; 2. Technology transfer support, including initiating technology transfer related SOPs, training, etc; 3. Audit, including supplier audit and self-inspection; 4.Change control/management; 5. others, such as site data integrity assurance, OOS/deviation investigation, initiating CAPAs.

① Manufacturing process optimizing of tablet, capsule, soft capsule and protein powder filling; ② Comparative research of BY-HEALTH'products and the rivals'; ③ Technology related training to the technicians; ④ Site audit and production supervision; ⑤ Provided necessary technical support to QA; ⑥ Acted as associate validation director, support qualification and validation activities.

Taking charge of R&D, registration, pilot up of serveral projects, such as recombinant human insulin, Orlistat, etc;