职位描述
Main Job Responsibilities:主要工作职责：1.Responsible for sample detection; 负责样品的检验 2.Responsible for development the new analytical method and related validation. 负责分析方法的开发及方法学验证。3. Parcitipate in the event invstigastion and take related action. 参与事件的调查及采取相应的行动。4.Support other functions in R&D. 支持研发中心其他功能组的工作5.Responsible for submission files preparation related with qulity. 负责注册文件质量研究部分的撰写。Work Experience, Technical/Professional Skills and Education Background Required: 工作经验、专业技能、学历等要求
1.Be familiar with requirements of <Pharmacopoeia of The People's Republic of China> /<Drug registration regulation> (current version) ect.熟悉现行版《中国药典》、《药品注册管理办法》等法规
2.Examine the sample with HPLC、GC、UV、AA et. And be able to maintain them daily.能使用 HPLC、GC、UV、AA等仪器进行检验，并进行日常维护保养。
3.Comprehend how to set up the drug's specification and be familiar with the knowlegde of analytical method validation . 懂得如何建立药品的质量标准，并具备分析方法验证的熟练技能。
4.Have experience on working or practicing in Institute of Guangdong or Guangzhou drug control .有在广东省或广州市药检所工作经验。
5.Be master or above on pharmacy or related science field. 药学或相关学科的硕士以上学位
6.The English level is above 6 degree.Be good at English reading,listening,writing and speaking.英语6级，具备良好的英语读、听、写和口语能力
7. Good submission file writing skill.良好的注册文件撰写能力。
