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Job Responsibilities 工作職責(zé)： 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(cè)規(guī)程，根據(jù)檢測(cè)規(guī)程，依照相關(guān)cGMP標(biāo)準(zhǔn)對(duì)中間樣品，原液，制劑和穩(wěn)定性樣品進(jìn)行分析檢測(cè)； 2.Perform routine testing such as endotoxin, bioburden and sterility, understand technical aspects of the job, best practices, and adhere to cGMP compliance. 執(zhí)行內(nèi)毒素，微生物限度和無菌的日常檢測(cè)，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 verification protocol under ICH/USP/EP/CP guidelines, and draft method verification report after the completion of experiment. 根據(jù)ICH/USP/EP/CP指南生成方法確認(rèn)方案，實(shí)驗(yàn)執(zhí)行完成后起草方法確認(rèn)報(bào)告； 4.Execute method transfer/qualification/validation of endotoxin, bioburden and sterility. 執(zhí)行內(nèi)毒素，微生物限度和無菌的方法確認(rèn)； 5. Perform moderate data analysis and trending, document work according to GMP and notify management. 進(jìn)行適當(dāng)?shù)臄?shù)據(jù)分析和趨勢(shì)分析，根據(jù)GMP進(jìn)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(fù)責(zé)處理與檢測(cè)相關(guān)的質(zhì)量事件，例如變更，偏差和糾正和預(yù)防措施。 Qualification 任職資格; 1.B.S./M.S. degree. 本科/碩士學(xué)歷。 2.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(yàn)，或研究生及一年以上工作經(jīng)驗(yàn)。 3.Extensive experience in micro related knowledge and testing skills. 具有豐富的微生物相關(guān)背景知識(shí)和檢測(cè)技能。 4.Excellent verbal and written communication skills in English. 有良好的英語口語和寫作能力。