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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，assist 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 verification. 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. 任職資格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 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.