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崗位職責(zé)：
1.負(fù)責(zé)分析有關(guān)的標(biāo)準(zhǔn)操作規(guī)程的審核。Responsible for reviewing the standard operation procedure related to analysis.
2.負(fù)責(zé)質(zhì)量標(biāo)準(zhǔn)、分析方法、分析方法驗(yàn)證/轉(zhuǎn)移方案及報(bào)告的審核與批準(zhǔn)。Responsible for reviewing and approving specification, analysis method, validation/transfer protocol and report of analysis method.
3.負(fù)責(zé)分析相關(guān)文件下發(fā)，回收及歸檔。Responsible for distributing, withdrawing and archiving documents related to analysis.
4.負(fù)責(zé)協(xié)助對(duì)檢測(cè)及分析驗(yàn)證過(guò)程中發(fā)生的OOS、異常事件及偏差的調(diào)查，以及變更評(píng)估。Responsible for assisting in the investigation on the OOS, OR and deviation and the evaluation on change control occurred in the process of test and analytical validation.
5.負(fù)責(zé)實(shí)驗(yàn)室分析儀器的確認(rèn)/驗(yàn)證文件審核。Responsible for reviewing qualification/validation documents ofanalytical instruments in laboratory.
6.負(fù)責(zé)實(shí)驗(yàn)室檢測(cè)數(shù)據(jù)審核。Responsible for review of analytical test data in laboratory.
7.負(fù)責(zé)實(shí)驗(yàn)室的日常巡檢。Responsible for routine inspection to laboratory.
8.負(fù)責(zé)合同實(shí)驗(yàn)室的管理及審計(jì)。Responsible for contract laboratory management and audit.
9.起草、修訂、審核與職責(zé)相關(guān)的文件、報(bào)告。Prepare, review, revise the documents/reports related to the responsibility.
10.協(xié)助客戶(hù)審計(jì)過(guò)程中的文件準(zhǔn)備、支持。Assist the documents preparation and support during client audit.
11.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(zhuān)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)QC工作經(jīng)驗(yàn)或者2年以上QA工作經(jīng)驗(yàn)。At least 5 years of QC or 2 years of QA working experience in the pharmaceutical or CRO industry.
3.具有一定的化學(xué)基礎(chǔ)知識(shí)。Have certain chemistry basic knowledge.
4.熟悉ICH Q7, GMP等相關(guān)法規(guī)。Familiar with ICH Q7, GMP and relevant regulations.
5.熟悉QC工作的相關(guān)要求。Familiar with QC work requirement.