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Job Responsibilities/工作職責(zé)
1. Participate in the implementation of environmental monitoring plan, including sampling, monitoring and trend analysis. Understand the post technical requirements and operation specifications to ensure cGMP compliance;
參與執(zhí)行環(huán)境監(jiān)測(cè)計(jì)劃，包括取樣、監(jiān)測(cè)和趨勢(shì)分析。理解崗位技術(shù)要求、操作規(guī)范，確保cGMP符合性；
2. Participate in the implementation of water system monitoring plan, including water system sampling and bio-burden testing, endotoxin testing and other physical and chemical analysis. Ensure cGMP compliance during implementation;
參與執(zhí)行水系統(tǒng)監(jiān)測(cè)計(jì)劃，包括水系統(tǒng)的取樣及微生物負(fù)載分析、內(nèi)毒素分析及其它理化分析等。確保執(zhí)行過程中cGMP符合性；
3. Participate in confirming whether the monitoring results of clean area, water system and gas are acceptable and distributing the results;
參與確認(rèn)潔凈區(qū)域、水系統(tǒng)及氣體的監(jiān)測(cè)結(jié)果是否可接受，以及結(jié)果分發(fā)；
4. Participate in drafting SOP and ensure the implementation of all relevant sops, and participate in training department members or other departments;
參與起草SOP并確保所有相關(guān)SOP執(zhí)行，參與培訓(xùn)部門成員或其他部門；
5. Participate in other work arranged by superior leaders.
參與上級(jí)領(lǐng)導(dǎo)安排的其他工作。
Job Requirements/崗位要求
1. College degree and above in a pharmaceutical, chemical or biological discipline;
大專以上學(xué)歷，藥學(xué)、化學(xué)或生物學(xué)相關(guān)專業(yè)；
2. Strong background in standard and specialized methodologies for biologics products preferred;
具有較強(qiáng)的生物制品檢測(cè)背景知識(shí)；
3. Thorough knowledge of GMP regulations and documentation, the basic statistics required in data analysis;
了解GMP法規(guī)和文件和基本數(shù)據(jù)分析統(tǒng)計(jì)學(xué)知識(shí)；
4. Preferably with excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory, ability to write technical documents.
良好的英文和普通話口頭和書面溝通能力 (聽、寫和說)，可以與其他職能部門和管理層溝通解決調(diào)查或理論問題，并具備撰寫技術(shù)文件的能力。