- 目錄
第1篇 無菌生產(chǎn)崗位職責
崗位職責:
負責無菌生產(chǎn)車間的生產(chǎn)管理工作。
崗位要求:
1、藥學相關(guān)專業(yè),本科及以上學歷;
2、三年以上制藥行業(yè)無菌車間生產(chǎn)管理工作經(jīng)驗;
3、較強的責任心,能吃苦耐勞,執(zhí)行力強。
第2篇 無菌生產(chǎn)經(jīng)理崗位職責
· educational /training教育背景
major in pharmaceutics, pharmaceutical science or related field
制藥學、藥劑學或相關(guān)學科
· working experiences工作經(jīng)驗
ms degree with a minimum of 3~4 years and ph.d. degree with a minimum of 2~3 years of pharmaceutical formulation experience
碩士最少3到4年,博士最少2到3年大分子制劑經(jīng)驗
· communication 溝通
excellent written and oral english skill. excellent communication/influence skill
良好的英文寫和說經(jīng)驗。良好的溝通能力。 · lead formulation and process development group to meet project timelines, departmental goals.
領(lǐng)導處方和工藝開發(fā)小組完成項目節(jié)點和部門目標。
· lead technology transfer for new and/or existing products into and out of client.
引導客戶的新(老)產(chǎn)品的技術(shù)轉(zhuǎn)移,包括轉(zhuǎn)進和轉(zhuǎn)出。
· plans, executes and manages both routine and non-routine projects simultaneously with general criteria for results
計劃、執(zhí)行和管理常規(guī)和非常規(guī)項目使得它們能得到一致的結(jié)果。
· performs data collection and analysis, discuss conclusions regarding progress of work, and effectively communicates information to supervisor in the form of discussions and reports.
執(zhí)行數(shù)據(jù)收集和分析,討論工作進展的結(jié)論,并以討論和報告的形式有效地向主管傳達信息。
· authors’ protocols, reports, technology transfer protocols/reports and other technical documents (i.e. master formula, specifications) as part of the product development and technology transfer process. author documents for regulatory submissions.
起草方案、報告、技術(shù)轉(zhuǎn)移方案和報告還有其他一些技術(shù)文檔(例如處方信息,產(chǎn)品說明書)作為產(chǎn)品開發(fā)和技術(shù)轉(zhuǎn)移的一部分。起草符合監(jiān)管機構(gòu)要求的文件。
· maintain effective, collaborative, and frequent interactions with client and other department to ensure harmonization in scientific and technical approaches.
與客戶和其他部門保持有效、協(xié)作和頻繁的溝通,以確??茖W和技術(shù)方法的協(xié)調(diào)。
· be a subject matter expertise commensurate with experience. solves problems using multiple problem-solving tools and techniques using appropriate resources, personal knowledge and experience with whatever data are available given the situation.
作為一個與經(jīng)驗相匹配的技術(shù)專家??梢岳眠m當?shù)馁Y源、個人知識和經(jīng)驗,多種工具和技術(shù)解決問題。
qualifications 任職資格
· educational /training教育背景
major in pharmaceutics, pharmaceutical science or related field
制藥學、藥劑學或相關(guān)學科
· working experiences工作經(jīng)驗
ms degree with a minimum of 3~4 years and ph.d. degree with a minimum of 2~3 years of pharmaceutical formulation experience
碩士最少3到4年,博士最少2到3年大分子制劑經(jīng)驗
· communication 溝通
excellent written and oral english skill. excellent communication/influence skill
良好的英文寫和說經(jīng)驗。良好的溝通能力。