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(xiě)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 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(jiàn)異物，不溶性微粒，裝量，顏色，濁度，液相相關(guān)和毛細(xì)管電泳相關(guān)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 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(rèn)/驗(yàn)證方案，實(shí)驗(yàn)執(zhí)行完成后起草方法轉(zhuǎn)移/確認(rèn)/驗(yàn)證報(bào)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(xì)管電泳相關(guān)的檢測(cè)方法的轉(zhuǎn)移和方法確認(rèn)/驗(yàn)證；

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，偏差和糾正及預(yù)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(fù)責(zé)編寫(xiě)穩(wěn)定性方案和報(bào)告，穩(wěn)定性樣品存儲(chǔ)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(fù)責(zé)樣品接收，存儲(chǔ)，分發(fā)和銷(xiāo)毀，分析檢測(cè)報(bào)告的出具。

Qualification 任職資格：

1.Bachelor’s/Master’s degree.

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(cè)試方面工作經(jīng)驗(yàn)，如高效液相色譜、毛細(xì)管電泳、質(zhì)譜、ICE3、紫外掃描等；對(duì)理化分析方法的方法開(kāi)發(fā)、確認(rèn)、驗(yàn)證和方法轉(zhuǎn)移方面有豐富經(jīng)驗(yàn)。

4.Understanding of FDA and ICH guidelines as well as GLP/GMP

principles associated with analytical development, the basic statistics
required in data analysis.

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(yǔ)口語(yǔ)和寫(xiě)作能力。