崗位職責(zé) Main Responsibilities

1. 負(fù)責(zé)組內(nèi)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(fù)責(zé)領(lǐng)導(dǎo)和執(zhí)行分析方法開發(fā)，驗證、分析儀器的確認(rèn)及/或領(lǐng)導(dǎo)進(jìn)行原料和產(chǎn)品的質(zhì)量控制等工作。能很好的指導(dǎo)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(fù)責(zé)儀器設(shè)備的正常運行和維護(hù)，配合主管審定本組所需試劑及備件，配合采購?fù)瓿刹少徣蝿?wù)。

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(fù)責(zé)樣品的分析測試并出具分析報告。

Responsible for sample test and draft testing report.

5. 負(fù)責(zé)產(chǎn)品穩(wěn)定性試驗方案的制定并按方案進(jìn)行穩(wěn)定性測試，為原料藥的有效期或復(fù)驗期及貯存條件的制定提供依據(jù)。

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(xié)助其他工廠分析實驗室的分析工作；做好方法轉(zhuǎn)移，培訓(xùn)當(dāng)?shù)胤治鰡T并協(xié)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(fù)責(zé)制定分析用儀器、設(shè)備、試劑、試液、標(biāo)準(zhǔn)品（或?qū)φ掌罚?、?biāo)準(zhǔn)液、培養(yǎng)基和菌種的管理辦法，并按規(guī)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(biāo)準(zhǔn)操作規(guī)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(guān)的操作規(guī)程和安全規(guī)程。

Follow related operation procedure and safety protocols.

10. 協(xié)助QA做好本部門的cGMP培訓(xùn)并遵守cGMP的有關(guān)法規(guī)。

Assist QA for cGMP training and follow relevant cGMP regulations.

11. 制定內(nèi)部培訓(xùn)計劃，定期進(jìn)行技術(shù)培訓(xùn)及專業(yè)培訓(xùn)。

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

任職資格 Qualification

1.教育背景：藥學(xué)、生物、醫(yī)學(xué)檢驗等相關(guān)專業(yè)

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

2.至少3年以上制藥企業(yè)QC微生物相關(guān)檢驗經(jīng)驗，2年以上管理經(jīng)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.