主要崗位職責(zé)Responsibilities：
?1.?負(fù)責(zé)制定并實(shí)施本企業(yè)質(zhì)量策略及方針、全面負(fù)責(zé)企業(yè)質(zhì)量管理工作；批準(zhǔn)與質(zhì)量相關(guān)的SOP，并推行其在公司內(nèi)部實(shí)施。
?????Define?QA?strategy?of?company.?Design,?implement?and?improve?company’s?quality?standards;?Train,?motivate,?coach?and?correct?employees?to?ensure?that?standards?are?met.?
?2.?與企業(yè)內(nèi)外相關(guān)部門協(xié)調(diào)溝通，應(yīng)對(duì)客戶及藥監(jiān)部門的審計(jì)工作。；
?????Coordinate?with?other?departments;?Deal?with?the?customer?audits?and?other?regulatory?inspections.
?3.?負(fù)責(zé)批準(zhǔn)原輔料、包裝材料、中間體、和成品符合質(zhì)量標(biāo)準(zhǔn)；
?????Approve?the?specifications?of?raw?materials,?intermediates,?products?and?packaging?materials.
?4.?負(fù)責(zé)批準(zhǔn)所有與質(zhì)量有關(guān)的變更、偏差、OOS和驗(yàn)證方案及報(bào)告；
?????Approve?all?the?changes,?deviations,?oos?investigation?reports,?validation?protocols?and?reports.
?5.?批準(zhǔn)物料供應(yīng)商，組織對(duì)供應(yīng)商的審計(jì)和評(píng)價(jià)；
?????Work?with?purchasing?staffs?to?establish?quality?requirements?for?external?suppliers.
?6.?組織實(shí)施公司質(zhì)量?jī)?nèi)審工作；
?????Organize?QA?annual?self-inspection.
?7.?負(fù)責(zé)組織處理與質(zhì)量相關(guān)的客戶抱怨；
?????Handle?of?quality?related?customer?complaints
?8.?負(fù)責(zé)指導(dǎo)質(zhì)量部門的日常工作，并對(duì)下屬進(jìn)行培訓(xùn)和考核；
?????Supervise?QA?and?QC?staffs?and?monitor?their?performance
??任職要求：
??Skills?and?Qualifications
?1.??具有藥學(xué)、化學(xué)或相關(guān)專業(yè)碩士及以上學(xué)歷，具有至少五年從事大中型知名制藥企業(yè)的質(zhì)量管理工作經(jīng)驗(yàn)。
?????Master’s?degree?in?pharmacy,?chemistry.?Five?plus?years?relevant?experience?of?QA?management?in?pharmaceutical?industry.?
?2.??具備出色的質(zhì)量管理能力，較強(qiáng)的統(tǒng)籌、協(xié)調(diào)、分析和判斷能力，良好的溝通協(xié)作能力，優(yōu)秀的組織和創(chuàng)新能力；
?????Solid?decision?making?skills.??Detail?oriented?person.?Good?ability?to?lead?and?motivate?a?team.
?3.??熟悉GMP要求下原料藥、生產(chǎn)環(huán)節(jié)的質(zhì)量控制，善于發(fā)現(xiàn)和解決問(wèn)題；熟悉GMP認(rèn)證資料準(zhǔn)備，有實(shí)際的中國(guó)、歐盟、FDA的GMP認(rèn)證經(jīng)驗(yàn)更佳。
?????Familiar?with?the?GMP?requirements?in?the?process?of?development?and?production?of?APIs.?Having???????experience?of?dealing?with?inspections?of?regulatory?organizations?is?preferred.
?4.??良好的英語(yǔ)口語(yǔ)及郵件交流能力，可以順暢地用英語(yǔ)與國(guó)外客戶進(jìn)行交流。
??????Excellent?English?communication?skills.
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