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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，assisit 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(jìn)行其他驗證工作；
Participate in reviewing of the validation protocol and report, coordinate
other departments with their verifications;
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(zé)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(zé)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.
教育背景和任職資格：
Education Background and Qualification:
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；
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(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(qiáng)的團(tuán)隊協(xié)作意識和溝通技巧；
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.