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Job Responsibilities/工作職責(zé) 1. Lead or participate in the implementation of environmental monitoring plan, including system implementation, plant confirmation and continuous monitoring (sampling, monitoring and trend analysis). Ensure the smooth progress of the monitoring work, and be responsible for the testing and monitoring results; 領(lǐng)導(dǎo)或參與環(huán)境監(jiān)測計(jì)劃實(shí)施，包括系統(tǒng)執(zhí)行、廠房確認(rèn)、持續(xù)監(jiān)測（取樣、監(jiān)測和趨勢分析）；保證監(jiān)測工作順利進(jìn)行，并對(duì)各項(xiàng)檢測及監(jiān)測結(jié)果負(fù)責(zé)； 2. Lead or participate in the implementation of process water system monitoring and gas monitoring plan to ensure that process water and gas medium meet the quality standard requirements; 領(lǐng)導(dǎo)或參與工藝用水系統(tǒng)監(jiān)測和氣體監(jiān)測計(jì)劃實(shí)施，確保工藝用水和氣體介質(zhì)符合質(zhì)量標(biāo)準(zhǔn)要求； 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)測結(jié)果是否可接受，以及結(jié)果分發(fā)； 4. Participate in the implementation of environmental monitoring, water system monitoring and gas monitoring related changes; Participate in the investigation of abnormal events, OOS/OOT and deviation; Ensure that the above changes and investigation process comply with relevant laws and regulations; 參與實(shí)施環(huán)境監(jiān)測、水系統(tǒng)監(jiān)測和氣體監(jiān)測的相關(guān)變更；參與實(shí)施相關(guān)的異常事件、OOS/OOT、偏差相關(guān)調(diào)查工作；確保上述變更及調(diào)查過程符合相關(guān)法規(guī)要求； 5. 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； 6. 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. BS degree and above in a pharmaceutical, chemical or biological discipline; 本科以上學(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。