工作內(nèi)容Job Description

1. 收集各部門年驗證項目，協(xié)助上級起草公司年驗證總計劃及驗證年度總結(jié)；

Collecting annual validation item of each department，assist superior to drafting annual validation plan and annual validation Summary.

2. 監(jiān)督各部門驗證計劃執(zhí)行情況；

Supervise the validation plan implementation of each departments.

3. 參與各部門驗證方案和驗證報告的審核, 配合其他部門進行其他驗證工作；

Participate in reviewing of the validation protocol and report, coordinate other departments

with their verification.

4. 監(jiān)督檢查在驗證實施中的偏差及整改措施；

Supervise and check the implementation of the deviation and corrective measures in validation.

5. 參與產(chǎn)品工藝驗證的實施，監(jiān)督關(guān)鍵工藝參數(shù)的實用性及偏差和整改措施，追溯驗證最終產(chǎn)品質(zhì)量的符合性；

Participate in implementation of product process validation, supervise the practicality of

critical process parameters, the deviation and corrective measures, track the conformity of the final product quality.

6. 起草、修訂與驗證有關(guān)的報告及規(guī)程；

Draft and revise the reports and procedures related to verification.

7. 起草、審核、修訂、復(fù)審職責相關(guān)的文件；

Prepare, review, revise, recheck the document related to the responsibility.

8. 起草審核本部門職責相關(guān)的報告；

Prepare and review the report related to the responsibility.

9. 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Qualification

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

Bachelor degree or above in chemistry or pharmaceutical or related majors. The requirements of

excellent personnel can be appropriately relaxed, including work experience.

2. 有 3年以上相關(guān)工作經(jīng)驗。

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. 具有很強的團隊協(xié)作意識和溝通技巧。

Have strong sense of teamwork and communication skills.

5. 具有較強的任務(wù)執(zhí)行能力。

Have strong ability of task execution.