崗位職責(zé)：
1.Implement?or?monitor?quality?system,?ensure?quality?system?running?effectively,?compliance?to?CGMP??requirement?in?QC?lab.
執(zhí)行或監(jiān)督質(zhì)量體系在QC實(shí)驗(yàn)室的運(yùn)行，確保質(zhì)量體系被有效運(yùn)行，符合現(xiàn)行GMP要求。
2.Maintain?laboratory?GMP?management?system?(GMP+HSE+?microbial)?to?ensure?data?integrity?compliant?to?GMP?requirement?and?there?are?no?serious?defects?in?GMP?audit.
維護(hù)實(shí)驗(yàn)室GMP管理系統(tǒng)（GMP+HSE+微生物），確保數(shù)據(jù)完整性符合GMP要求，GMP審計(jì)無(wú)嚴(yán)重缺陷。
3.Cooperate?test?work?in?new?project.?Provide?professional?technical?support?for?process?validation,?cleaning?validation?and?new?product.
配合新項(xiàng)目的檢驗(yàn)。為工藝驗(yàn)證、清潔驗(yàn)證和新產(chǎn)品注冊(cè)工作提供專業(yè)技術(shù)支持。
4.Ensure?high?quality,?low?cost?and?timely?completion?of?inspection?of?raw?materials,?intermediates,?packaging?materials,?finished?products?(including?the?stability?of?sample)?and?other?relevant?inspection?such?as:?process?validation,?cleaning?validation,?etc.
確保高質(zhì)量、低成本并及時(shí)完成原輔料、中間體、內(nèi)外包材、成品（包括穩(wěn)定性樣品）以及其他相關(guān)檢驗(yàn)如：工藝驗(yàn)證、清潔驗(yàn)證等。
5.Ensure?QC?chemical?reagent,?working?standard,?specification,?test?method,?etc.?compliant?to?GMP?/?Pharmacopeia?requirement.?Lead?all?staff?in?QC?chemical?Lab?and?microbial?Lab?to?finish?test?work,?issue?test?result?and?report
確保實(shí)驗(yàn)室使用試劑對(duì)照品，質(zhì)量標(biāo)準(zhǔn)檢驗(yàn)方法等符合GMP和藥典要求。帶領(lǐng)所有理化實(shí)驗(yàn)室和微生物實(shí)驗(yàn)室員工，完成檢驗(yàn)工作，出具檢驗(yàn)數(shù)據(jù)和報(bào)告
6.Organize?Analytical?instrument?/?equipment?qualification?/?validation,?maintenance?and?preventative,?computerized?system?and?audit?trial?compliant?to?GMP?requirement.
組織實(shí)驗(yàn)室分析儀器的確認(rèn)/驗(yàn)證、維護(hù)保養(yǎng)，計(jì)算機(jī)系統(tǒng)和審計(jì)追蹤符合GMP要求。
7.Management?and?monitoring?of?stability?programs.
穩(wěn)定性計(jì)劃的管理和監(jiān)控。
8.Conduct?internal?audit/?and?monitoring?progress?in?related?GMP?area.
執(zhí)行內(nèi)部審計(jì)和GMP監(jiān)控。
9.Be?in?charge?of?investigation?on?laboratory?deviation?and?OOS/OOT,?Quality?risk?assessment?and?CAPA?track?in?responsible?area.
負(fù)責(zé)實(shí)驗(yàn)室偏差、OOS/OOT實(shí)驗(yàn)室調(diào)查，負(fù)責(zé)的工作領(lǐng)域進(jìn)行適時(shí)的質(zhì)量風(fēng)險(xiǎn)評(píng)估，CAPA的追蹤。
10.Closely?support?for?work?in?other?functional?department.?Participate?in?product?quality?improvement.
緊密支持其他部門工作。參與產(chǎn)品質(zhì)量改進(jìn)。
11.Create?an?open,?relax?and?continues?study?and?work?environment?in?QC?department.?Train?analysts.
組建一個(gè)開(kāi)放、積極和持續(xù)改進(jìn)的工作環(huán)境。培訓(xùn)檢驗(yàn)員。
12.Be?in?charge?of?the?Health-Safety-Environment?in?his/her?position/workstation?as?the?first?person.
作為第一HSE負(fù)責(zé)人對(duì)職責(zé)范圍（崗位）內(nèi)的職業(yè)健康安全環(huán)境工作負(fù)責(zé)。
13.Complete?other?work?assigned?by?supervisor.
完成上級(jí)安排的其它工作。
Must?to?have?:最低要求
？Education教育:?bachelor’?degree?學(xué)士學(xué)位。
？Professional?/Major專業(yè)：?Analytical?chemistry??or?related分析化學(xué)或相關(guān)專業(yè)。
？Experience?經(jīng)驗(yàn):?8years?experience?in?QC?lab?，2?years?QC?management?experience.8年QC工作經(jīng)驗(yàn),其中2年以上QC管理經(jīng)驗(yàn)。
？Language語(yǔ)言:?Good??written?and?spoken?English?良好的英語(yǔ)聽(tīng)說(shuō)能力。
？IT?Skill電腦技能:?Excel?software?會(huì)使用EXCEL。
？Other?Ability其他能力:?Good?ability?to?communicate?with??colleagues.良好的溝通能力。