Experience in Merck of quality system.默克质量系统工作经验Rotation to quality system from 2017/03/15, act as quality SME for SAP project (including the interface with LIMS) and computerized system validation (CSV) life cycle management2017/03/15转岗至质量系统，主要负责SAP项目（包括SAP与LIMS的接口）， 计算机化系统生命周期管理Act as a quality SME to provide the quality in-put to Merck LEAN SAP project, build up good working relationships and clear communications with Merck Global LEAN SAP rollout team作为默克质量部SME参与到LEAN SAP中，并与默克总部同事建立起良好的工作氛围以及清晰的交流机制Act as the Site Lead User for TrackWise and ManGo (Management for GxP and ISO Documents), such as the authorization/incidents/change/SOP management and so on.作为默克南通工厂TrackWise以及ManGo（Management for GxP and ISO Documents）SLU（Site Lead User），主要负责相关权限/事件/变更/SOP管理等等。Cooperate with local business team and global project team to identify new requirements and any potential risk/issue for LEAN SAP project, and make quality decision to ensure system GMP compliance沟通本地以及总部项目实施团队，识别LEAN SAP项目的新需求以及可能存在的风险点，并做出质量决定来确保系统GMP合规Leading and follow up change impact risk assessment for LEAN SAP project from QA side, proposal risk remediation for each identified risk, and escalate to local management team and global quality team从QA角度牵头负责LEAN SAP项目风险分析，给出风险减缓措施，并且反馈到本地管理以及总部质量团队Leading the local business process and system operation SOPs refresh/updating due to LEAN SAP rollout牵头由LEAN SAP项目所引发的本地业务以及系统操作SOP的更新Cooperate with global EQQ QA colleague for Computerized System Validation in LEAN SAP project, such as build up test scripts, defect management, and setting quality gate for functionality transportation between development/quality assurance/production systems and so on跟总部EQQ QA同事合作关于LEAN SAP项目计算机化系统验证工作，比如建立测试脚本，缺陷管理，在系统功能进行切换转移时设定质量控制点等等Supporting GMP inspection readiness from Health Authorities, and support to address findings from regulation inspections支持来自官方的审计工作，并处理任何发现项

Experience in Merck of microbiological lab默克微生物实验室工作经验Establish GMP compliant microbiological lab, including microbiological testing and validation procedure, utility (purified water, soften water, city water, compressed air and cleaning rooms) performance qualification and daily monitoring procedure, equipment qualification and re-qualification procedure建立GMP合规微生物实验室，包括：微生物方法验证及测试方法，公用设施（纯化水、软化水、城市供水、压缩空气和洁净室）性能确认及日常监控，设备确认及再确认Handling change control and deviation during Micro-lab Design and Build phase默克建厂项目期间微生物实验室偏差调查以及变更管理Participate in quality control lean lab project, such as 5S and data integrity projects.精益实验室项目，如5S及数据完整性项目

Nearly 1 and half years of experience of equipment qualification in WuXi Apptec.大约1年半实验室设备确认经验（药明康德）Follow the procedure of equipment or instruments qualification and re-qualification, such as HPLC/GC/UV/Analytical Balance/pH Meter in chemical lab, and Autoclave and Chambers in Microbial lab.按照化学或者微生物实验室标准操作流程进行设备的确认与再确认，比如化学实验室的HPLC/GC/分析天平/紫外，微生物实验室的灭菌锅/培养箱等等Responsible for facing quality inspection from customers such as Lily or Amgen regarding the qualification perspective, and flexibly address any issue during audit and up-coming any finding负责处理来自客户（礼来或者安进）的仪器设备确认方便的审计，并且灵活处理审计过程中的各种问题以及接下来的发现项目

4 years of experience in field of microbiology & quality control of oral dosages (Solids, capsules) in Novast.4年固体口服片剂胶囊微生物质量检疫经验（联亚）Preform media preparation and autoclave loads, maintain and subculture the standard pure cultures配置培养基并且灭菌，实验室工作用菌培养及继代保存Responsible for daily purified water monitoring, and in charge of environment/equipment/facility bio-burden testing.纯化水的日常监测，洁净区环境及设备的微生物负载监控Responsible for the microbial analysis of raw material, package material, finished products, product development samples.原辅料/包材/成品/产品开发样品微生物限度检测Participate in the writing and training of SOPs, STMs, protocols and reports.参加实验室STM/SOP/Protocol 撰写以及培训In case of OOS or other incidents, report it to group leader immediately, and ensure a proper handling of it.出现OOS的情况，及时汇报给领导，合理地处理好