main responsibilities主要职责: 1、 Responsible for the test of raw materials, excipient materials, packaging materials, finished products (solution, emulsion and suspension, etc.), stability and other samples, and writing the test records. 负责洁净区环境监测工作,包括但不限于沉降菌、悬浮粒子、浮游菌的采样及培养等。 2、 Responsible for sample reception, distribution and sampling management of stability samples. 负责进行样品的接收,发放以及稳定性检测样品的取样管理。 3、 Responsible for the management of the stability test box and refrigerator for storing samples. 负责存放样品的稳定性试验箱以及冰箱的相关管理工作。 4、 Responsible for the management of equipment for EM. 负责环境监测相关设备的管理工作。 5、 Responsible for the sampling of raw materials, excipients and packaging materials and also the management of sampling tools. 负责原辅料,包装材料的取样工作以及取样器具的管理工作。 6、 Responsible for the management of sampling room. 负责取样室的管理。 7、 Draft detail operating procedures for stability chamber and other instruments制定稳定性箱及其他设备的详细操作规程。 8、 Support the qualification of related instruments 支持相关仪器的确认。 9、 Perform daily maintenance and cleaning of instruments and equipment. 执行仪器设备的日常维护和清洁。 10、 Review the original data and records, carry out data statistics, and cooperate with the analysis and review of historical data in the later period. 复核检验原始数据和记录,并开展数据统计工作,配合后期的历史数据分析及回顾。 11、 Other work arranged by the leader领导安排的其他工作 job requirement任职条件: 1、 Education: College degree or above in science or engineering with major in chemistry, biochemistry, pharmacy, biological engineering, etc. 学历: 化学、生物化学、制药、生物工程等专业的专科或以上学历。 2、 Familiar with FDA and Chinese Good Manufacturing Practice (GMP and cGMP) requirements熟悉FDA及中国药品生产质量管理规范的要求 (GMP及cGMP)。 3、 Work experience: MORE than 2 years experience in GMP site, at least familiar with environment monitoring test in grade A to grade D. 工作经验:2年以上GMP现场工作经验,至少熟悉A级至D级环境监测试验。 4、English level: able to read and understand professional English terminology,and can draft bilingual SOP in writing. 英语水平: 能够阅读理解专业英语术语,USP,并能书面起草双语SOP。