崗位職責(zé)：

1. 學(xué)習(xí)國(guó)家藥品法律、法規(guī)，以指導(dǎo)質(zhì)量管理工作；

Learn national drug law and regulations, in order to guide the quality management work.

2. 分析現(xiàn)場(chǎng)日常巡查，確?，F(xiàn)場(chǎng)執(zhí)行和SOP、法規(guī)要求的一致性；

Responsible for perform on-site daily inspection, and make sure the compliance between the operation on-site and SOP and regulation.

3. 審核與分析相關(guān)的文件，包括質(zhì)量標(biāo)準(zhǔn)、分析方法；

Review the documents related to analysis, including quality standards and analysis methods.

4. 審核分析終產(chǎn)品的檢驗(yàn)記錄和分析證書；

Review the records and certificate of analysis of the final products;

5. 審核分析相關(guān)的電子數(shù)據(jù)；

Review the electronic data related to analysis；

6. 審核對(duì)照品標(biāo)定方案和對(duì)照品分析證書；

Review the reference standard qualification protocol and certificate of analysis;

7. 審核分析方法驗(yàn)證方案、驗(yàn)證報(bào)告；

Review the protocols and reports of analytical method validation;

8. 審核產(chǎn)品穩(wěn)定性方案和報(bào)告；

Review the protocols and reports of stability;

9. 合同實(shí)驗(yàn)室的管理；

Responsible for the management of QC contract laboratory;

10. 儀器驗(yàn)證文件編號(hào)的下發(fā)；

Issue the file number of analytical instrument validation.

11. 審核分析儀器確認(rèn)、驗(yàn)證方案和報(bào)告；

Review the protocols and reports of analytical instrument validation and verification;

12. 審核分析儀器用戶需求標(biāo)準(zhǔn)（URS）；

Review the User Requirement Specification of analytical instrument;

13. 協(xié)助分析系統(tǒng)相關(guān)的變更、偏差、CAPA、OOS的管理；

Assist in the completion of the management of change control、 deviation、CAPA and OOS which are related to QC.

14. 下發(fā)、回收分析相關(guān)的質(zhì)量標(biāo)準(zhǔn)、驗(yàn)證方案等；

Distribute the specification, validation protocols related to analysis;

15. 完成本部門領(lǐng)導(dǎo)安排的其他工作。

Complete the work assigned by the leaders.

任職資格：

1. 具有化學(xué)、制藥及相關(guān)專業(yè)本科及以上學(xué)歷，優(yōu)秀人員可適當(dāng)放寬條件，包括工作經(jīng)驗(yàn)。

Bachelor degree or above in chemistry or pharmaceutical or related majors excellent personnel requirement can be appropriately related to include work experience.

2. 有3年以上相關(guān)工作經(jīng)驗(yàn)。

Have 3 years or above work experience.

3. 熟悉原料藥相關(guān)GMP法規(guī)。

Familiar with GMP and relevant regulations about API.

4. 具有很強(qiáng)的團(tuán)隊(duì)協(xié)作意識(shí)和溝通技巧。

Have strong sense of teamwork and communication skills.

5. 具有較強(qiáng)的任務(wù)執(zhí)行能力。

Have strong ability of task execution.