Provide technical support for utilities and equipment qualification and process validation; Take part in reviewing SOPs related to manufacturing and technical documents;Assist in handling change control and deviation investigation;Organize process verification and resolution of technical problems in manufacturing;Participate in GMP self inspection;Make monthly manufacturing plans.

• Lead the technical team to manage the OTC product validation activities including prepare master batch record, draft and review final project report;• Monitor and control product process parameter to continuity quality improvement base on statistic data analysis;• Provide necessary product process document to support Regulatory Affair Department on ANDA submission;• Conduct performance qualification of process equipment including Granulator, Capsule filler, Tablet Presser, Coater etc.;• Draft risk assessment report of manufacturing process for commercial production;• Organize risk assessment of computer system for process equipment;• Inspect process discipline on site and solve process problem for oral solid products focus on scale up and PV stage;• Lead team to prepare SOPs related to manufacturing process;• Train the manufacturing personnel on process technology to improve their technical level;• Lead team to take technical transfer of product both from internal and client.

• Participated in project management, followed up project progress;• Developed a generic tablet product form lab experiment , to scale up and submission for CFDA;• Developed a pellet product from scale up study and submission;• Drafted QS, MBR, R&D protocol and reports.

• Investigate and survey on new projects to obtain enough information for formulation development;• Conduct pre-formulation research of IND product including physical and chemical characters of raw materials, stability test and compatibility study;• Research and develop formulation and optimize process focus on oral solid dosage;• Participated in technical transfer of ANDA products.