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崗位職責 Main Responsibilities

1. 負責組內的工作并解決工作中的問題。

Responsible for the work within team and solve problems occurred in routine work.

2. 負責領導和執行分析方法開發，驗證、分析儀器的確認及/或領導進行原料和產品的質量控制等工作。能很好的指導分析員完成工作。

Responsible for leading and performing method development, validation, instrument qualification and quality control of raw material and product, and is able to guide the analyst to finish the job in good manner.

3. 負責儀器設備的正常運行和維護，配合主管審定本組所需試劑及備件，配合采購完成采購任務。

Responsible for equipment in good operation and maintenance, cooperate with the manager to determine requirement of reagents and spare parts, and work with purchase group for purchase task.

4. 負責樣品的分析測試并出具分析報告。

Responsible for sample test and draft testing report.

5. 負責產品穩定性試驗方案的制定并按方案進行穩定性測試，為原料藥的有效期或復驗期及貯存條件的制定提供依據。

Responsible for establishing stability study protocol and perform stability test according to protocol, provide evidence for shelf life or re-test date and storage condition establishment.

6. 協助其他工廠分析實驗室的分析工作；做好方法轉移，培訓當地分析員并協助解決分析中遇到的問題。

Provide assistance of analytical work in other site labs; Perform method transfer and train the local analyst and solve problems in testing work.

7. 負責制定分析用儀器、設備、試劑、試液、標準品（或對照品）、標準液、培養基和菌種的管理辦法，并按規定實施。

Responsible for establishing the management protocol of analytical instrument, equipment, reagent, solution, standard (or reference material), medium and strains, and execute according to protocol.

8. 撰寫并審核分析文件，例如分析方法，方法驗證方案，報告和標準操作規程等。

Draft and review analytical documents, such as test method, method validation protocol and report and standard operation procedure, etc.

9. 遵守相關的操作規程和安全規程。

Follow related operation procedure and safety protocols.

10. 協助QA做好本部門的cGMP培訓并遵守cGMP的有關法規。

Assist QA for cGMP training and follow relevant cGMP regulations.

11. 制定內部培訓計劃，定期進行技術培訓及專業培訓。

Make internal training plan, and provide training technical and professional knowledge periodically.

任職資格 Qualification

1.教育背景：藥學、生物、醫學檢驗等相關專業

Bachelor degree or above inpharmacy, biology, medical examination or other related fields

2.至少3年以上制藥企業QC微生物相關檢驗經驗，2年以上管理經驗；英語聽說讀寫熟練，熟悉GMP要求，熟練使用Microsoft office辦公軟件。

Minimum 3 years of microbial testing experience in Quality control department in pharmaceutical company, at least 2 years of lab management working experience; fluent in English (both oral and written), familiar with GMP requirement, skilled in Microsoft office software.