岗位职责: 1.Responsible for the biochemical testing for product. 负责产品的生化检测。 2.Responsible for outsourcing biochemical test. 负责生化委托检验工作。 3.Initialing or revising of biochemical testing related SMP, SOP, MOP, protocol or reports, etc. 起草或修订生化检测相关SMP、SOP、MOP、方案和报告等。 4.Responsible for management of reagents and consumables. 负责试剂及耗材的管理。 5.Investigation and execution of OOS/OOT/atypical result occurred in the testing process. 检测过程中出现的OOS/OOT/异常检验结果的调查及执行。 6.Ensure the routine operations meet the requirements of GMP and EHS. 确保日常操作符合GMP及EHS的要求。 7.Any other tasks assigned by supervisors. 领导指派的其他任务。
任职要求: 1.Bachelor’s degree and above required in a relevant discipline (Pharmacy, Biology or related), 相关学科(药学、生物学或相关专业)本科及以上学历。 2.At least 2 year related work experience,work experience of biochemicals testing in (bio)Pharmaceutical industry. 从事相关工作经验至少2年,从事过生物制药生化检测。 3.Familiar with GMP, ChP, USP, EP and other regulations. 熟悉GMP、ChP、USP、EP等法规。 4.Ability to complete testing tasks and problem solving independently. 独立完成检测任务及解决问题能力。 5.Good communication skills, excellent organization and coordination ability, and analytical judgment ability. 善于沟通,具备出色的组织协调能力及分析判断能力。