Principal?Accountabilities?(Major?end?results?the?job?is?expected?to?achieve)
主要工作職責(zé)（主要工作成就，期望此職位達到的目標(biāo)）
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Perform?routine?micro?testing,?e.g.?bioburden,?sterility?test?etc.,?and?deliver?report?in?time
進行常規(guī)的微生物測試，例如：生物負載、無菌測試等，并及時出具報告
Perform?CA,?PW?and?environmental?monitoring?and?other?process?including?culture/media?preparation
壓縮空氣、純化水和環(huán)境監(jiān)測以及菌種/培養(yǎng)基制備等其他日常工作
Review?data?obtained?for?compliance?to?specifications?and?report?abnormalities
審核獲得的數(shù)據(jù)是否符合質(zhì)量標(biāo)準以及報告的異常性
Troubleshoot?microbiological?OOS?occurrences?and?support?change?controls,?CAPAs?and?investigations
解決微生物OOS問題及協(xié)助變更控制，CAPAs和調(diào)查
Plan,?write,?perform?and?follow?method?validation,?equipment?qualification,?cleaning?validation?and?sterilization?validation?protocols/reports
計劃、編寫、執(zhí)行和跟蹤方法驗證、設(shè)備確認、清潔驗證和滅菌驗證相關(guān)方案/報告
Perform?required?calibration/maintenance?on?microbiological?equipment
對微生物設(shè)備執(zhí)行所要求的校驗/維護
Ensure?safe?working?in?accordance?with?cGMP/HSE?guideline?at?all?time
始終按照cGMP/HSE規(guī)范確保安全工作
To?review?data?and??perform?the?data?trend?analysis,?complete?the?related?annual?summary?report
審核數(shù)據(jù)，并完成數(shù)據(jù)趨勢分析，完成相關(guān)項目的年度總結(jié)報告
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Other?tasks?assigned?by?the?supervisor
主管分配的其他工作
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?Knowledge?and?Experience?(Knowledge?and?experience?needed?for?satisfactory?
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??????performance?of?the?job)
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?????資質(zhì)和經(jīng)驗（此職位所要求的資質(zhì)和經(jīng)驗）
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Education-bachelor’s?degree?in?Microbiology?or?related?field
教育-微生物相關(guān)專業(yè)本科學(xué)歷。
Experience-?3?years?work?experience?in?quality?assurance/quality?control?lab?and?/or?
???????related?field.
經(jīng)驗-在質(zhì)量保證/質(zhì)量控制實驗室和/或相關(guān)領(lǐng)域3年以上經(jīng)歷。
Must?have?understanding?of?compendial?requirements,?ISO?13485/cGMP?regulations?and?microbiological???
???????techniques.
必須了解法規(guī)，?ISO?13485/cGMP法規(guī)和微生物技術(shù)。
Familiarity?with?validation?activities,?additional?specialized?training?helpful?(e.g.?gamma?sterilization?or?ETO?sterilization)
熟悉驗證活動、有額外的專業(yè)培訓(xùn)更好（如γ滅菌或ETO滅菌）
Desirable要求
Experience?in?the?Medical/Pharmaceutical/Chemical?industry有在醫(yī)療/制藥經(jīng)驗
Have?little?microbiology?lab?management有部分微生物實驗室管理工作經(jīng)歷
-?????Experience?of?working?in?a?foreign?owned?company
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?????????????外企工作經(jīng)驗
