Jack Li Email & Phone Number

Suzhou, Jiangsu, China

Take the responsibility of the overall management of OSD (small molecule)manufacturing function, including routine production management and technical service.

Changping District, Beijing, China

Process/product oversight and knowledge:Maintain the oversight of the process of the product(s) assigned at the Site.Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle, since transfer from development to dateSingle Point of Contact to Global Product Steward:Liaise with Global Product Steward at global level and locally with functions, production management, shopfloor, with focus to ensure and improve product process capability, to keep up to date the knowledge of process and to maintain the product in constant state of validationCreate and maintain a product specific Quality Risk Analysis (QRAs)Continued Process Verification (CPV), data trending and statistical analysis:Track CPV parameters from production , QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned product(s) (CPP, IPC parameters, Quality Attributes, Characteristics of raw materials. Etc) using statistical analysis and conducting regular product specific data trendingUtilize data trending and statistical analysis to:o Deepen and broaden process understanding and knowledgeo Detect issues in process capability, such as systematic quality defectso Identify trends of process deviationso Issue quarterly/annual data trending reportAssist initiating the product-specific monitoring of all IPC and release parameters in each laboratory (transfer of the product-specific Quality Risk Analysis)Ensure data and trending is visible and communicated at shopfloor levelValidation:Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samplesSupport to assess need and plan validations / re-validations / verifications / Annula Monitoring Batches, consulting approving and reviewing the process validation master plan, together with the Validation LeadApproves both Validation Protocols and Report

Taizhou, Jiangsu

在项目建设阶段负责项目的跟进、设备的试运行和确认、交接、验证、团队组建、人员培训等，在商业化运营时负责生产业务流程日常管理，制定标准操作规范。常规工作包括计划的完成，操作规范，成本，资产，cGMP，SHE以及精益生产。直接管理团队，负责团队和成员的绩效管理和技能提升。

Mba, 工商管理

Bachelor'S Degree, Food Quality And Safety