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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 residual HCP, residual DNA, residual ProA, mycoplasma test, potency tests which include binding ELISA potency test and cell based potency test, understand technical aspects of the job, best practices, and adhere to cGMP compliance. 執(zhí)行殘留HCP，殘留DNA，殘留ProA，支原體檢測，酶聯(lián)免疫活性和細胞活性實驗的日常檢測，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 residual HCP, residual DNA, residual ProA, mycoplasma test, potency tests which include binding ELISA potency test and cell based potency test. 執(zhí)行殘留HCP，殘留DNA，殘留ProA，支原體檢測，酶聯(lián)免疫活性和細胞活性實驗的方法轉(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，偏差和糾正和預(yù)防措施。

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. 本科及三年以上工作經(jīng)驗，或研究生及一年以上質(zhì)量控制工作經(jīng)驗。

3.Strong background in standard and specialized methodologies for biologics products; Experience developing bioassays and biophysical potency assays, developing process impurity assays such as HCP, Residual DNA, and Residual ProA methods is preferred. 具有生物產(chǎn)品方法開發(fā)或檢測的相關(guān)背景，有生物活性檢測方法和其他生物學(xué)實驗方法開發(fā)，雜質(zhì)分析方法開發(fā)（如HCP，殘留DNA和殘留ProA方法）的工作經(jīng)驗者優(yōu)先考慮； 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(xué)； 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。