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規(guī)程,根據(jù)檢測規(guī)程,依照相關(guān)cGMP標(biāo)準(zhǔn)對中間樣品,原液,制劑和穩(wěn)定性樣品進(jìn)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(xì)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(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)和銷毀,分析檢測報(bào)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.
本科及三年以上工作經(jīng)驗(yàn),或研究生及一年以上質(zhì)量控制工作經(jīng)驗(yàn)。
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(yàn),如高效液相色譜、毛細(xì)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(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.
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(jì)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。