工作內(nèi)容Job Description：

1. 審核公司質(zhì)量管理文件和質(zhì)量管理體系與新頒布的國家法規(guī)的符合性；

Review the compliance of the quality management document with the new published laws and regulations.

2. 協(xié)助進行國外藥政法規(guī)、行業(yè)指南的查詢，及時了解國外藥品管理的新動向，對本公司質(zhì)量管理提出新的要求及糾正預(yù)防措施；

To assist leader for searching the external regulatory laws and regulations, industry guidelines, and understanding the new trend of the external drug management in time, proposing new requirement and CAPA to quality management of the company.

3. 管理組內(nèi)的工作并解決工作中的問題；

Responsible for managing the work assigned to the and solving work problems.

4. 負責與相關(guān)部門團隊協(xié)調(diào)溝通，將工作任務(wù)進行合理分配；

Responsible for communicating with relevant department and team, assign work reasonably.

5. 負責審計中職責相關(guān)缺陷整改工作；

Responsible for the response to the corrective action of the observations relevant to responsibility during the audit.

6. 負責變更、偏差、CAPA、投訴、退貨、召回及質(zhì)量協(xié)議的管理；

Management of Change Control, Deviation, CAPA, Complaint, Return, Recall and Quality Agreement management.

7. 維護、審核GMP 相關(guān)部門的組織機構(gòu)圖，關(guān)鍵崗位人員職責；

Maintenance and review the GMP organization chart and the responsibility of the key position staffs.

8. 組織進行年度計劃、質(zhì)量回顧等總結(jié)性工作；

Organize annual plan, quality review and other summary work.

9. 負責物料相關(guān)工作的管理；

Responsible for material management related work.

10. 協(xié)助部門領(lǐng)導(dǎo)負責外部質(zhì)量活動溝通工作；

Assist department leader to communicate with external quality activities

11. 負責供應(yīng)商管理工作；

Responsible for supplier management.

12. 協(xié)助上級起草審核本部門職責相關(guān)工作；

Prepare and review the work related to the responsibility；

13. 組織進行內(nèi)部審計；

Organize that internal audits are taken regularly.

14. 協(xié)助部門領(lǐng)導(dǎo)進行日常事務(wù)管理；

Assist department leaders in daily affairs management.

15. 監(jiān)督質(zhì)量管理系統(tǒng)的執(zhí)行是否符合要求；

Supervise the implementation of the quality management system to meet the requirements.

16. 完成本部門領(lǐng)導(dǎo)安排的其他工作。

Complete the work assigned by supervisor.

任職資格Qualification

1. 具有化學(xué)、制藥及相關(guān)專業(yè)本科學(xué)歷。

Bachelor degree in chemistry or pharmaceutical or related majors.

2. 有3年以上相關(guān)工作經(jīng)驗。

Have 3 years or above work experience.

3. 熟悉ICH Q7,GMP 等相關(guān)法規(guī)。

Familiar with ICH Q7, GMP and relevant regulations.

4. 有較強的工作條理性、計劃性。

Have a strong work ethic and planning.

5. 具有一定的語言基礎(chǔ)（中英文互譯）。

Have a certain language foundation (Chinese-English translation).

6. 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.

7. 具有較強的任務(wù)執(zhí)行能力。

Have strong ability of task execution.