職位描述
Main Job Responsibilities:主要工作職責(zé)：1.Responsible for sample detection; 負(fù)責(zé)樣品的檢驗(yàn) 2.Responsible for development the new analytical method and related validation. 負(fù)責(zé)分析方法的開(kāi)發(fā)及方法學(xué)驗(yàn)證。3. Parcitipate in the event invstigastion and take related action. 參與事件的調(diào)查及采取相應(yīng)的行動(dòng)。4.Support other functions in R&D. 支持研發(fā)中心其他功能組的工作5.Responsible for submission files preparation related with qulity. 負(fù)責(zé)注冊(cè)文件質(zhì)量研究部分的撰寫(xiě)。Work Experience, Technical/Professional Skills and Education Background Required: 工作經(jīng)驗(yàn)、專業(yè)技能、學(xué)歷等要求
1.Be familiar with requirements of <Pharmacopoeia of The People's Republic of China> /<Drug registration regulation> (current version) ect.熟悉現(xiàn)行版《中國(guó)藥典》、《藥品注冊(cè)管理辦法》等法規(guī)
2.Examine the sample with HPLC、GC、UV、AA et. And be able to maintain them daily.能使用 HPLC、GC、UV、AA等儀器進(jìn)行檢驗(yàn)，并進(jìn)行日常維護(hù)保養(yǎng)。
3.Comprehend how to set up the drug's specification and be familiar with the knowlegde of analytical method validation . 懂得如何建立藥品的質(zhì)量標(biāo)準(zhǔn)，并具備分析方法驗(yàn)證的熟練技能。
4.Have experience on working or practicing in Institute of Guangdong or Guangzhou drug control .有在廣東省或廣州市藥檢所工作經(jīng)驗(yàn)。
5.Be master or above on pharmacy or related science field. 藥學(xué)或相關(guān)學(xué)科的碩士以上學(xué)位
6.The English level is above 6 degree.Be good at English reading,listening,writing and speaking.英語(yǔ)6級(jí)，具備良好的英語(yǔ)讀、聽(tīng)、寫(xiě)和口語(yǔ)能力
7. Good submission file writing skill.良好的注冊(cè)文件撰寫(xiě)能力。
