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Job Responsibilities/工作職責
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，液相相關的檢測，毛細管電泳相關的檢測的日常檢測，理解工作的技術原理，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指南生成方法轉移/確認/驗證方案，實驗執(zhí)行完成后起草方法轉移/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，液相相關的檢測，毛細管電泳相關的檢測的方法轉移和方法確認/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的質(zhì)量事件，例如變更，偏差和糾正和預防措施。
Job Requirements/崗位要求
1. Bachelor’s degree in a scientific discipline with 3+ years’ experience in quality control systems, or Master’s degree with 1+ years’ experience;
本科及三年以上工作經(jīng)驗，或研究生及一年以上工作經(jīng)驗；
2. 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；具有在理化分析方法的方法開發(fā)、確認、驗證和方法轉移方面有豐富經(jīng)驗；
3. 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)相關的GLP / GMP原則和數(shù)據(jù)分析所需的基本統(tǒng)計學；
4. Highly motivated, flexible, and multi-task;
高度積極性，靈活性和多任務解決能力；
5. Excellent verbal and written communication skills in English.
有良好的英語口語和寫作能力。