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工作內(nèi)容CONTENT
1. 按照已批準(zhǔn)的生產(chǎn)規(guī)程/批記錄進行制劑的生產(chǎn)。
Produce drug product according to approved production procedure/ batch record.
2. 按照項目計劃安排小組人員班次生產(chǎn)。
Arrange the production personnel according to project plan.
3. 審核所有的現(xiàn)場記錄，確保記錄完整并已簽名。
Review all site records and ensure that these are completed and signed.
4. 確保生產(chǎn)設(shè)施是清潔的，在必要時消毒，對已清潔的設(shè)備進行目視檢查及簽發(fā)清場“清場合格證”正副本。
Make sure that production facilities are cleaned and disinfected when necessary, and perform visual check for cleaned equipment and issue “Clearance Certificate”(Original and Copy) for clearance.
5. 確保生產(chǎn)設(shè)備被校驗并有效。
Make sure that the equipment calibrations are performed and valid.
6. 確保驗證方案和報告的審核與執(zhí)行。
Make sure that validation protocols and reports are reviewed and executed.
7. 確保新的或經(jīng)過改造的（必要時）生產(chǎn)設(shè)施和設(shè)備通過確認(rèn)。
Make sure that new or modified (when necessary) facilities and equipment are qualified.
8. 確保生產(chǎn)現(xiàn)場整潔，對設(shè)備設(shè)施實行定置定位管理。
Make sure that the production site is tidiness, and conduct positioning management for facilities and equipment.
9. 確保操作人員在GMP 制劑實驗室操作、行為符合SOP規(guī)定。
Make sure that the operation and action of operator in PPD_GMP-Lab are following SOP.
10. 確保GMP制劑實驗室文件記錄完整，及時。
Make sure that all records of PPD_GMP-Lab are completed in time.
11. 調(diào)查和評估生產(chǎn)偏差，并上報QA。
Investigate and evaluate the production deviations, and report to QA.
12. 起草SOP、驗證文件。
Draft SOPs and validation documents.
13. 完成其他相關(guān)工作。
Execute other related tasks.
教育背景和任職資格EDUCATION BACKGROUND and QUALIFICATION
1. 藥物制劑、制藥工程或相關(guān)專業(yè)專科或以上學(xué)歷。
College degree or above in pharmaceutical preparation, pharmaceutical engineering or related majors
2. 兩年以上生產(chǎn)管理或相關(guān)工作經(jīng)驗。
At least 2 years’ experience in production management or related work
3. 了解相關(guān)制藥法規(guī)，如《中華人民共和國藥品管理法》和GMP法規(guī)。
Understand the relevant pharmaceutical laws and regulations, such as “The Drug Administration Law of the PRC” and “Good Manufacturing Practices”
4. 熟悉產(chǎn)品的工藝過程、SOP、質(zhì)量控制點，掌握關(guān)鍵設(shè)備的性能和操作。
Familiar with the product process, SOP, quality control point, master the performance and operation of key equipment.
5. 具有工藝問題分析能力、設(shè)計方案能力、判斷能力、操作能力、與他人溝通能力。
Have ability to analyze process problems, design protocols, judge, operate and communicate with others.
6. 熟悉電腦文檔操作。
Familiar with computer documentation operation