A.Principal?Accountabilities?(Major?end?results?the?job?is?expected?to?achieve)主要工作職責(zé)(主要工作成就,期望此職位達(dá)到的目標(biāo))1.To?perform?media?preparation?to?ensure?all?media?and?reagents?are?available?for?routine?testing執(zhí)行培養(yǎng)基配制工作,確保日常監(jiān)測(cè)需要的培養(yǎng)基和試劑可以獲得??2.Be?involved?in?the?routine?test?and?stability?test執(zhí)行常規(guī)的微生物測(cè)試和穩(wěn)定性測(cè)試3.Perform?PW?and?environmental?monitoring純化水和環(huán)境監(jiān)測(cè)工作4.Be?responsible?for?lab?equipment?calibration/?qualification/?validation?activities校驗(yàn),確認(rèn)和維護(hù)微生物實(shí)驗(yàn)室設(shè)備5.Support?test?method?and?other?process?validation?(e.g.?cleaning?validation?and?EM?validation)支持或者執(zhí)行檢驗(yàn)方法和工藝驗(yàn)證(如清潔驗(yàn)證和環(huán)境驗(yàn)證)6.Be?responsible?for?the?sample?receiving?and?management?of?retaining?sample,?consumable?and?reagent負(fù)責(zé)樣品接收和管理留樣、易耗品和試劑7.Be?responsible?for?the?stock?management負(fù)責(zé)庫(kù)存管理8.Ensure?working?in?accordance?with?cGMP/HSE?guidelines?and?Quality?standards?at?all?time.確保時(shí)刻遵循cGMP?,?安全和質(zhì)量的要求9.Support?change?controls,?CAPAs?and?OOS?investigations.協(xié)助變更控制、CAPA和偏離規(guī)格調(diào)查10.Be?involved?in?lab?special?optimization?project?if?needed需要時(shí),參與實(shí)驗(yàn)室優(yōu)化項(xiàng)目11.Work?as?a?collaborative?team?member團(tuán)隊(duì)合作12.Other?tasks?assigned?by?the?supervisor主管分配的其他工作???B.Job?Context?/?Key?Challenges工作內(nèi)容/主要的挑戰(zhàn)??1.Control?and?management?of?consumables?and?media?in?laboratory實(shí)驗(yàn)室耗材和培養(yǎng)基的管理和控制2.Supports?manufacturing?and?QA?in?providing?testing?activities?in?accordance?to?the?testing?requirements?as?per?the?product?files.根據(jù)產(chǎn)品測(cè)試要求為生產(chǎn)和QA提供測(cè)試3.Ensure?timely?completion?of?product?testing確保及時(shí)完成產(chǎn)品的測(cè)試4.Identification?of?optimization?activities?during?the?laboratory?working?process識(shí)別工作過(guò)程中的可優(yōu)化活動(dòng)?C.Dimensions?(Relevant?facts?and?figures?relating?to?job)?職責(zé)范圍(與此職位相關(guān)的事務(wù)與指標(biāo))1.Management?of?laboratory?inventory?and?consumables管理實(shí)驗(yàn)室?guī)齑婧鸵缀钠?.Trouble?shooting?of?any?OOS/OOT?issues對(duì)超標(biāo)和異常的事件進(jìn)行問(wèn)題分析D.Knowledge?and?Experience?(Knowledge?and?experience?needed?for?satisfactory?performance?of?the?job)資質(zhì)和經(jīng)驗(yàn)(此職位所要求的資質(zhì)和經(jīng)驗(yàn))Essential?主要的??Education-graduated?from?a?technical?secondary?school?in?microbiology?or?related?field.教育?-??微生物或相關(guān)專業(yè)中專以上學(xué)歷Experience-?One?year?or?above?work?experience?in?microbiology?lab.經(jīng)驗(yàn)?-??1年或以上微生物實(shí)驗(yàn)室工作經(jīng)驗(yàn)Good?communication?and?responsibility.良好溝通技巧和責(zé)任感Desirable?額外的Experience?in?the?Medical?device醫(yī)療器械行業(yè)經(jīng)驗(yàn)Experience?of?working?in?a?foreign?owned?company外企工作經(jīng)驗(yàn)