崗位職責(zé)JD： 1、 Conduct external supplier audit as required by the company 按照公司的要求進(jìn)行外部供應(yīng)商審計(jì) 2、 Have ability to complete external supplier audit independently after training 經(jīng)過培訓(xùn)后能夠獨(dú)立完成外部供應(yīng)商審計(jì) 3、 Conduct pre-audit communication according to audit requirements and make audit arrangements 根據(jù)審計(jì)要求進(jìn)行審計(jì)前溝通，確定審計(jì)安排 4、 Conduct on-site audit according to audit requirements 按照審計(jì)要求進(jìn)行現(xiàn)場審計(jì) 5、 Adhere to audit requirements, complete audit report, CAPA audit, audit closure and so forth. 按照審計(jì)要求完成審計(jì)報(bào)告、CAPA審核和審計(jì)關(guān)閉等工作 6、 Maintain and ensure that suppliers are in approved status 維護(hù)并確保供應(yīng)商處于批準(zhǔn)狀態(tài) 7、 Complete other tasks assigned by leaders 完成領(lǐng)導(dǎo)交代的其他事情 任職需求： 1、 Good English reading and writing skills, fluent oral English is preferred 有較好的英語讀寫能力，有良好的英語口語溝通能力優(yōu)先 2、 At least 2-years working experience in System QA or production process management or QC department management 至少2年以上的體系QA或生產(chǎn)工藝管理或QC部門管理的工作經(jīng)驗(yàn) 3、 Familiar with GMP or relevant regulations, FDA, EU and other quality related regulations 熟悉GMP或相關(guān)規(guī)定，熟悉FDA，EU等質(zhì)量相關(guān)法規(guī) 4、 Bachelor degree or above in Pharmacology related field 藥學(xué)相關(guān)專業(yè)本科或以上學(xué)歷 5、 Good problem solving and analytical skills 良好的問題解決和分析能力 6、 Good at communication and Decision Making; 良好的溝通技巧和決策能力； 7、 Planning/Organizing with effective Communication Teamwork 通過有效的溝通和團(tuán)隊(duì)合作進(jìn)行規(guī)劃/組織