工作內容：
Job Description:
1. 收集各部門年驗證項目，協助上級起草公司年驗證總計劃及驗證年度總結；
Collecting annual validation item of each department，assisit superior to drafting annual validation plan and annual validation Summary;
2. 監督各部門驗證計劃執行情況；
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 verifications;
4. 監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. 參與產品工藝驗證的實施，監督關鍵工藝參數的實用性及偏差和整改措施，追溯驗證最終產品質量的符合性；
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、修訂與驗證有關的報告及規程；
Draft and revise the reports and procedures related to verification;
7. 起草、審核、修訂、復審職責相關的文件；
Prepare, review, revise, recheck the document related to the responsibility;
8. 起草審核本部門職責相關的報告；
Prepare and review the report related to the responsibility;
9. 完成本部門領導安排的其他工作。
Complete the work assigned by the leaders.
教育背景和任職資格：
Education Background and Qualification:
1. 具有化學、制藥及相關專業本科及以上學歷，優秀人員可適當放寬條件，包括工作經驗；
Bachelor college or above in chemistry or pharmaceutical or related majors.
The requirements of excellent personnel can be appropriately relaxed, including work experience;
2. 有3年以上相關工作經驗；
Have 3 years or above work experience;
3. 熟悉原料藥相關GMP 法規；
Familiar with GMP and relevant regulations about API;
4. 具有很強的團隊協作意識和溝通技巧；
Have strong sense of teamwork and communication skills;
5. 具有較強的任務執行能力。
Have strong ability of task execution.