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1. Generate all necessary test procedure, perform analysis of in-process sample, drug substance, drug product and stability study sample under cGMP standards. 撰寫所有必須的檢測規(guī)程，根據(jù)檢測規(guī)程，依照相關(guān)cGMP標準對中間樣品，原液，制劑和穩(wěn)定性樣品進行分析檢測； 2.Perform routine testing such as pH, osmolality, UV, visible particle, Sub-visible particle, extractable volume, color, clarity, LC related assay, CE related assay, understand technical aspects of the job, best practices, and adhere to cGMP compliance. 執(zhí)行pH, 滲透壓，蛋白濃度，可見異物，不溶性微粒，裝量，顏色，濁度，液相相關(guān)和毛細管電泳相關(guān)的日常檢測，理解工作的技術(shù)原理，最佳做法，并遵守cGMP合規(guī)性； 3.Generate method transfer/qualification/validation protocol under ICH/USP/EP/CP guidelines, and draft method transfer/qualification/validation report after the completion of experiment. 根據(jù)ICH/USP/EP/CP指南生成方法轉(zhuǎn)移/確認/驗證方案，實驗執(zhí)行完成后起草方法轉(zhuǎn)移/確認/驗證報告； 4.Execute method transfer/qualification/validation of as pH, osmolality, UV, extractable volume, color, clarity, LC related assay, CE related assay. 執(zhí)行pH, 滲透壓，蛋白濃度，裝量，顏色，濁度，液相相關(guān)，毛細管電泳相關(guān)的檢測方法的轉(zhuǎn)移和方法確認/驗證； 5.Perform moderate data analysis and trending, document work according to GMP and notify management. 進行適當?shù)臄?shù)據(jù)分析和趨勢分析，根據(jù)GMP進行文件工作并通知管理人員； 6.Handle the quality event such as change control, deviation and CAPA related to the testing. 負責處理與檢測相關(guān)的質(zhì)量事件，例如變更，偏差和糾正及預防措施； 7. Stability study administrator which in charge of stability protocol/report preparation and storage/management of stability sample. 穩(wěn)定性研究管理主要負責編寫穩(wěn)定性方案和報告，穩(wěn)定性樣品存儲和管理。 8.Sample administrator which mainly responsible for sample receipt/ storage/distribution/disposal, test report and CoA issuance. 樣品管理主要負責樣品接收，存儲，分發(fā)和銷毀，分析檢測報告的出具。 Qualification 任職資格： 1.Bachelor’s/Master’s degree. 本科/碩士。

2.Bachelor’s degree in a scientific discipline with 3+ years’ experience in quality control systems, or Master’s degree with 1+ years’ experience.

3.Extensive experiences in analytical testing for protein analysis, such as HPLC, CE, MS, iCE3，UV, extensive experience in method development,qualification, validation and method transfer of physical-chemical methods. 具有蛋白質(zhì)分析測試方面工作經(jīng)驗，如高效液相色譜、毛細管電泳、質(zhì)譜、ICE3、紫外掃描等；對理化分析方法的方法開發(fā)、確認、驗證和方法轉(zhuǎn)移方面有豐富經(jīng)驗。 4.Understanding of FDA and ICH guidelines as well as GLP/GMP principles associated with analytical development, the basic statistics required in data analysis. 了解FDA和ICH指南以及與分析方法開發(fā)相關(guān)的GLP / GMP原則和數(shù)據(jù)分析所需的基本統(tǒng)計學。 5.Highly motivated, flexible, and multi-task. 高度積極性，靈活性和多任務(wù)解決能力。 6.Excellent verbal and written communication skills in English. 有良好的英語口語和寫作能力。