職位描述
MAJOR ACCOUNTABILITIES主要職責1.??????????? Take responsibility for Product Transfer and development.負責產品轉移與研發工作。Establish good cooperation relationship with each part that is related of product transfer target. 與轉移各方建立良好的合作關系。Follow the technical trial (laboratory, pilot trial), registration and validation batch, and scale batch producing. 主導產品的小試、中試至工藝放大全過程。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. 編寫原輔料、產品標準，生產工藝規程; 組織編寫原輔料、產品的檢測方法，設備確認與工藝驗證等文件。2.??????????? Organization of Preparation of Submission dossiers.協調申報資料準備。3.??????????? Ensure process and document compliance that shall be reliant with authority regulation and procedure of UCB product transfer.產品轉移與研發操作須符合相關的監管法規和UCB產品轉移的相關程序。 ?JOB PROFILE (Education & Experience)?? 崗位要求 (學歷及經驗)Education 學歷Relevant pharmaceutical major, at least bachelor 藥學及其相關專業，本科以上學歷Experience經驗Good knowledge in Drug registration regulation, Good professional skill and knowledge in solid oral dosage development. 熟悉藥品注冊法規，掌握口服固體制劑研發的專業技能。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，中試及檢驗工作背景；曾經獨立編寫新藥注冊資料。Good English, office software skill.英語、辦公軟件熟練
