崗位職責(zé)
1.直接下屬4人。負(fù)責(zé)實(shí)驗室QA團(tuán)隊的人員管理，工作安排，績效管理，團(tuán)隊建設(shè)與人才培養(yǎng)。There are 4 direct reporting QA specialists. Responsible for personnel management, work arrangement, performance management, team building and talent development of the laboratory QA team.
2.負(fù)責(zé)QC理化實(shí)驗室與微生物實(shí)驗室以及AD實(shí)驗室的QA監(jiān)管。Responsible for QA supervision of the QC physical/chemical laboratory, microbiology laboratory, and AD laboratory.
3.負(fù)責(zé)批準(zhǔn)質(zhì)量標(biāo)準(zhǔn)，分析方法及CoA。Responsible for approving the issued specification, analysis method and CoA.
4.負(fù)責(zé)實(shí)驗室標(biāo)準(zhǔn)操作規(guī)程的審核與批準(zhǔn)。Responsible for reviewing and approving the standard operation procedure.
6.負(fù)責(zé)分析實(shí)驗室OOS，異常事件，偏差及變更的審核與批準(zhǔn)。Responsible for review and approving the OOS, OR, deviation and change control in analytical laboratory.
7.負(fù)責(zé)分析實(shí)驗室檢測數(shù)據(jù)審核批準(zhǔn)，分析儀器驗證報告的審核批準(zhǔn)。Responsible for review and approval of analytical laboratory test data and analytical instruments qualification reports.
8.負(fù)責(zé)分析方法驗證的方案和報告批準(zhǔn)。Responsible for review and approving the method validation protocol and reports.
9.負(fù)責(zé)確保分析實(shí)驗室的日常監(jiān)督檢查有效執(zhí)行，批準(zhǔn)巡檢報告.Responsible for ensuring the effective implementation of routine inspection in the analytical laboratory and approve the routine inspection reports.
10.負(fù)責(zé)合同實(shí)驗室的管理及審計。Responsible for contract laboratory management and audit.
11.起草分析實(shí)驗室管理相關(guān)的質(zhì)量管理文件。Draft quality management documents related to the management of analytical laboratories.
12.參與客戶審計及相關(guān)準(zhǔn)備工作。Participate in customer audits and related preparation work.
13.完成領(lǐng)導(dǎo)安排的其他工作。Complete the work assigned by leaders.

任職資格：
1.本科或以上學(xué)歷，化學(xué)、藥學(xué)、制藥工程等相關(guān)專業(yè)。 Bachlor or above degree in chemistry or pharmaceutical or related majors.
2.五年以上制藥或CRO行業(yè)QA+QC工作經(jīng)驗。熟悉理化、微生物實(shí)驗室工作流程與要求，AD實(shí)驗室的方法驗證工作，有豐富的實(shí)驗室調(diào)查與偏差調(diào)查經(jīng)驗，At least 5 years of QA+QC working
experience in the pharmaceutical or CRO industry, be familiar with the process and requirements in QC physical/chemical laboratory, microbiology laboratory and method validation in AD lab, with experiences of lab investigation and deviation investigation.
3.具有領(lǐng)導(dǎo)力，能帶領(lǐng)團(tuán)隊高效完成業(yè)績，支持團(tuán)隊進(jìn)行跨部門、跨場區(qū)溝通與問題解決。有QA或者QC團(tuán)隊管理工作經(jīng)驗優(yōu)先考慮.Have leadership skills and be able to lead the team to achieve excellent performance. Support the team in conducting cross-departmental and cross-site area communication and problem-solving. Prior experience in QA or QC team management is preferred.QA or QC team management experience is preferred.
4.熟悉ICH Q7,GMP等相關(guān)法規(guī)。 Familiar with ICH Q7, GMP and relevant regulations.
5.有很強(qiáng)的工作條理性、計劃性及任務(wù)執(zhí)行能力。具有很強(qiáng)的跨廠區(qū)、跨部門溝通能力，團(tuán)隊協(xié)作意識和溝通技巧。Have a strong work logic，planning ability and strong ability of task execution. Have strong ability of cross-site & cross-department communication, sense of teamwork and communication skills.
6.英語口語流利。Fluent in oral English.