職位描述
MAJOR ACCOUNTABILITIES主要職責(zé)1.??????????? Take responsibility for Product Transfer and development.負(fù)責(zé)產(chǎn)品轉(zhuǎn)移與研發(fā)工作。Establish good cooperation relationship with each part that is related of product transfer target. 與轉(zhuǎn)移各方建立良好的合作關(guān)系。Follow the technical trial (laboratory, pilot trial), registration and validation batch, and scale batch producing. 主導(dǎo)產(chǎn)品的小試、中試至工藝放大全過(guò)程。Write Specification of material and product, manufacturing process instruction, organize documents preparation of testing methods of material and product, qualification of equipment, and product validation. 編寫(xiě)原輔料、產(chǎn)品標(biāo)準(zhǔn)，生產(chǎn)工藝規(guī)程; 組織編寫(xiě)原輔料、產(chǎn)品的檢測(cè)方法，設(shè)備確認(rèn)與工藝驗(yàn)證等文件。2.??????????? Organization of Preparation of Submission dossiers.協(xié)調(diào)申報(bào)資料準(zhǔn)備。3.??????????? Ensure process and document compliance that shall be reliant with authority regulation and procedure of UCB product transfer.產(chǎn)品轉(zhuǎn)移與研發(fā)操作須符合相關(guān)的監(jiān)管法規(guī)和UCB產(chǎn)品轉(zhuǎn)移的相關(guān)程序。 ?JOB PROFILE (Education & Experience)?? 崗位要求 (學(xué)歷及經(jīng)驗(yàn))Education 學(xué)歷Relevant pharmaceutical major, at least bachelor 藥學(xué)及其相關(guān)專業(yè)，本科以上學(xué)歷Experience經(jīng)驗(yàn)Good knowledge in Drug registration regulation, Good professional skill and knowledge in solid oral dosage development. 熟悉藥品注冊(cè)法規(guī)，掌握口服固體制劑研發(fā)的專業(yè)技能。Good career on oral drug development, technical trial, product test and analysis part. Can write and organize the documents for drug registration. 口服固體制劑研發(fā)，中試及檢驗(yàn)工作背景；曾經(jīng)獨(dú)立編寫(xiě)新藥注冊(cè)資料。Good English, office software skill.英語(yǔ)、辦公軟件熟練
