1.?????Ensure?the??appropriate?microbiological?tests?are?performed?in?compliance?with???SOP?of?Baxter?Suzhou,?Baxter?specifications,??corporate?and?local?regulatory?requirements.
確保微生物實驗室各項分析方法均符合蘇州百特SOP，百特技術標準，符合?當?shù)卣蠛托袠I(yè)規(guī)定。????
2.?????To?support??the?micro?lab?in?technical?perspectives?to?ensure?fulfill?the?tasks?with??quality,?right?cycle?time?and?compliant?with?the?regulatory?and?corporate??requirements.???
支持微生物實驗室擁有正確的技術，確保高質(zhì)量的、在正確的周期內(nèi)完成任務，并且與法規(guī)和總部要求是保持一致的。?
3.?????Lead?a?team??of?microbe?&?calibration?in?providing?prompt?microbiological/calibration??services?to?support?manufactory’s?activities.?
領導微生物/校驗團隊提供快速的微生物/校驗服務以支持工廠行動。?
4.?????Take??responsible?for?new?method?validation?/?method?transfer?including?preparing??validation?/?transfer?plan,?deviation?investigation?during?executing?and??preparing?the?final?report,?personal?training?etc.???
負責新的方法驗證/方法轉(zhuǎn)移包括驗證/轉(zhuǎn)移計劃的準備，執(zhí)行期間的偏差調(diào)查以及最終報告的準備，人員的培訓等等。??
5.?????Take??responsible?for?existing?methods?optimization?including?validation?for?the??changed?method.?
負責對現(xiàn)有方法的優(yōu)化包括方法變更的驗證。?
6.?????Be??responsible?for?lab?equipment?qualification/?validation?activities.??
負責實驗室設備的確認/驗證。
7.?????Write?and??update?relevant?standard?operation?procedures?in?Micro-lab.
編寫和更新微生物實驗室相關標準操作程序。
8.Ensure??proper?documentation?(e.g.?change?control,?data?traceability)?and?integrity?of??data,?calculations?and?results?reporting?in?accordance?with?GLP?requirements.
確保合適的文件（如變更控制，數(shù)據(jù)的追溯性）和數(shù)據(jù)的完整性，按照實驗室規(guī)范的要求計算和報告結果。
9.?Be?leading??the?lab?internal?audit?and?external?audit.
領導實驗室內(nèi)部及外部審核。
10.Be?leading??in?new?or?junior?analyst?training?and?verification.
領導新員工或下級分析員的培訓和確認。
11.?Be?involved??in?micro-lab?related?project.
微生物實驗室內(nèi)其他相關項目。
12.Ensure?the??appropriate?calibration?tests?are?performed?in?compliance?with???SOP?of?Baxter?Suzhou,?Baxter?specifications,??corporate?and?local?regulatory?requirements.
確保校驗方法均符合蘇州百特SOP，百特技術標準，符合當?shù)卣蠛托袠I(yè)規(guī)定。
13.Ensure?proper??calibration?requirements?(e.g.?technical?&?documentation)?in?according?with??Baxter?Suzhou.
????????????????????????????????????????????????????
保證蘇州百特滿足校驗需求。
職位要求：
1.?????Process?a??certificate?in?relative?majors.
微生物或其他相關專業(yè)。
2.?????Minimum?5??years?relevant?working?experience?in?the?pharmaceutical?or?related?industry??working?experiences?in?related?areas,?and?with?at?least?of?2?management??experiences.
????????????至少五年以上在制藥或相關企業(yè)的工作經(jīng)歷，并且有至少2年的管理經(jīng)驗。
3.???Have?the??comprehensive?knowledge?of?microbiology?and?RA.
有全面的微生物和法規(guī)相關知識。
4.???Knowledge??of?ISO?and?GMP?etc.
具有ISO和GMP等方面的知識。
5.???Able?to??communicate?well?with?others.
善于與他人建立良好的關系。
6.???Be?familiar??with?office.
熟悉?office軟件
7.???Be?fluent??in?English?language.
????????????????????????????????????英語流利。