微生物技術(shù)員的職責(zé)英文描述
微生物技術(shù)員負(fù)責(zé)落實(shí)實(shí)驗(yàn)室領(lǐng)導(dǎo)的工作安排。以下是學(xué)習(xí)啦小編整理的微生物技術(shù)員的職責(zé)英文描述。
篇一
執(zhí)行原輔料、包裝材料、中間產(chǎn)品的取樣
Raw materials, excipients and intermediate sampling
執(zhí)行日常微生物相關(guān)的檢驗(yàn),包括微生物限度檢查、細(xì)菌內(nèi)毒素檢查及無(wú)菌檢查等
Perform routine microbial related analysis, including microbial limit test, endotoxin test and sterility test
水系統(tǒng)及潔凈環(huán)境的日常監(jiān)控
Water system and clean environment monitoring
培養(yǎng)基、菌懸液及其他實(shí)驗(yàn)相關(guān)試劑的制備
Preparation of culture media, buffer solution and microbial strain for testing
協(xié)助OOS/OOT/偏差的調(diào)查
Asist OOS/OOT/Non-compliance investigation
工作要求Job Requirement ?
大專(zhuān)及以上學(xué)歷,藥學(xué),微生物學(xué)或生物技術(shù)相關(guān)專(zhuān)業(yè) College or above degree in Pharmacy, Microbial, Biotechnical, ? 了解中國(guó)藥典、美國(guó)藥典、歐洲藥典及GMP/cGMP/歐盟GMP的相關(guān)要求 Understand the ChP/USP/EP and theGMP/cGMP/EU GMP ?
熟悉無(wú)菌檢查、微生物限度檢查、細(xì)菌內(nèi)毒素檢查等藥品微生物的檢測(cè)及方法驗(yàn)證 Familiar with the sterility test/microbiology limit test/endotoxin test and also the TMV ?
熟練掌握細(xì)菌內(nèi)毒素檢測(cè)儀器、無(wú)菌檢查隔離器、脈動(dòng)真空滅菌柜、微生物鑒定儀等常用設(shè)備的使用 Familiar with the usage of common equipment such as endotoxin testing equipment, isolator, autoclave, ID detector, etc.
醫(yī)藥行業(yè)1年以上微生物實(shí)驗(yàn)室工作經(jīng)驗(yàn) 1 years working experience in pharmaceutical Micro-lab
英語(yǔ)水平良好,熟練使用Office軟件 Good English,and familiar with Office software
篇二
1.Cleanroom environment testing : particle count test, airborne micro test, setting micro test, surface micro test and so on.
潔凈室環(huán)境監(jiān)控包括懸浮粒子測(cè)試,浮游菌測(cè)試, 沉降菌測(cè)試, 表面微生物測(cè)試等等。
2.Perform bioburden test, bioburden validation test, LAL Test (kinetic turbidimetric limulus test), LAL Validation test
負(fù)責(zé)細(xì)菌內(nèi)毒素測(cè)試、細(xì)菌動(dòng)態(tài)和比濁測(cè)試,驗(yàn)證,執(zhí)行生物負(fù)載測(cè)試和驗(yàn)證。
3.Perform RO water test, EO Residues test
負(fù)責(zé)純凈水測(cè)試,環(huán)氧乙烷殘留量測(cè)試
4.Prepare medium, perform 5S and other jobs.
執(zhí)行5S測(cè)試,和其他工作
篇三
1. Perform routinemicrobiological testing and ensure that all microbiological related works areperformed in compliance with SOPs.
進(jìn)行每天的微生物測(cè)試并確保微生物所有相關(guān)工作符合SOPs。
2. Perform testequipments basic maintenance and use in compliance with SOPs.
按照SOPs的要求執(zhí)行設(shè)備的基本維護(hù)和使用。
3. Strictly followlaboratory safety practice & responsible for disposal of biohazardmaterials.
嚴(yán)格遵守實(shí)驗(yàn)室的安全規(guī)范,負(fù)責(zé)生物廢棄物的處理。
4. Ensure and work incompliance with all EHS aspects.
確保工作符合環(huán)保、健康和安全的方針政策。