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Job Responsibilities 工作職責(zé)： 1.Responsible for cleaning equipment and cleaning areas, maintaining related facilities, and maintaining personal health and hygiene. 負(fù)責(zé)的清潔設(shè)備和潔凈區(qū)域，維護(hù)相關(guān)設(shè)施，保持個(gè)人的健康和衛(wèi)生； 2.Complete relevant training as required, and operate strictly in accordance with SOPs and BPRs. Strictly ensure that all production processes comply with the requirements of GMP and pharmaceutical production regulations. 按要求完成相關(guān)的培訓(xùn)，嚴(yán)格根據(jù)標(biāo)準(zhǔn)操作規(guī)程和批生產(chǎn)記錄來(lái)操作；嚴(yán)格保證根據(jù)所有生產(chǎn)流程符合GMP和藥品生產(chǎn)法規(guī)的要求； 3.Drafting and revising the documents of the production department, and filling in production-related applications and records. Author Shake Flask Cell Culture GMP documents. Author Bioreactor Cell Culture GMP documents. Author Harvest GMP documents. Author media/buffer preparation, washing and sterilization GMP documents. Author work clothes washing and production area cleaning GMP documents. 起草、修改生產(chǎn)部的文件，填寫生產(chǎn)相關(guān)的申請(qǐng)和記錄；起草搖瓶細(xì)胞培養(yǎng)生產(chǎn)相關(guān)的GMP文件；起草生物反應(yīng)器細(xì)胞培養(yǎng)生產(chǎn)相關(guān)的GMP文件；起草收獲相關(guān)的GMP文件。起草培養(yǎng)基/緩沖液配制、清洗和滅菌相關(guān)的GMP文件；工衣清洗相關(guān)的GMP文件； 4.Participate in the daily activities of production preparation, activities of the Shake Flask Cell Culture manufacturing, the production support, the Bioreactor Cell Culture manufacturing, activities of the harvest manufacturing group, cell culture in the bioreactor, including sampling, passage, counting, feeding, and on-duty, sampling, depth filtration and sterilization filtration, cell recovery, sampling, counting, passage in shake flask and cryopreservation, and preparation of small-scale media, the weighing and preparation of large-scale media and buffers, the washing of work clothes, the monitoring of the production process, review documents, the media/buffer weighing, preparation, washing and sterilization. check all calculations (such as BPRs, labels, equipment readings, etc.). 參與生產(chǎn)準(zhǔn)備，搖瓶細(xì)胞培養(yǎng)生產(chǎn)，生物反應(yīng)器細(xì)胞培養(yǎng)生產(chǎn)，生產(chǎn)輔助，收獲生產(chǎn)的日?；顒?dòng)；生物反應(yīng)器中的細(xì)胞培養(yǎng)，包括取樣、傳代、計(jì)數(shù)、補(bǔ)料、值班；細(xì)胞的收獲，包括取樣，深層過(guò)濾和除菌過(guò)濾；大規(guī)模培養(yǎng)基和緩沖液的稱量和配制; 培養(yǎng)基/緩沖液稱量、配制、清洗、滅菌；參與工衣的清洗；細(xì)胞的復(fù)蘇，取樣，計(jì)數(shù)，搖瓶傳代和凍存，小規(guī)模培養(yǎng)基的配制；生產(chǎn)過(guò)程的監(jiān)控，審閱文件，檢查所有的計(jì)算（例如批生產(chǎn)記錄，標(biāo)簽，設(shè)備的讀數(shù)等）； 5.Make production schedule and plan, cooperate with the project manager, communicate with external engineers and suppliers, lead the team to complete the company's production tasks. 制定生產(chǎn)排程和計(jì)劃，與項(xiàng)目經(jīng)理以及其他部門合作，與外部工程師和供應(yīng)商溝通，領(lǐng)導(dǎo)團(tuán)隊(duì)完成公司的生產(chǎn)任務(wù)； 6.Lead the optimization of production process, troubleshooting to reduce production cost and solve complex process or equipment problems. 領(lǐng)導(dǎo)生產(chǎn)工藝的優(yōu)化和故障排除，以降低生產(chǎn)成本和復(fù)雜工藝或設(shè)備問(wèn)題的解決； 7.Manage the documents of the production department and review the reports related to production, check all calculations (e.g. batch records, label, equipment reading). 管理生產(chǎn)部的文件，審核與生產(chǎn)相關(guān)的報(bào)告，檢查所有計(jì)算（如：批記錄、標(biāo)簽、設(shè)備讀數(shù)）； 8.Organize personnel/resources for Bioreactor Cell Culture manufacturing, Shake Flask Cell Culture manufacturing, harvest manufacturing media/buffer preparation, washing and sterilization, Work Clothes Washing, Sterilization, Sorting & Distribution, Production Area Cleaning, regulated according to cGMP to accomplish department goals and objectives while operating in a safe manner and in compliance with all applicable regulations. 按cGMP的要求，組織人員/資源，執(zhí)行物反應(yīng)器細(xì)胞培養(yǎng)生產(chǎn)，搖瓶細(xì)胞培養(yǎng)生產(chǎn)，培養(yǎng)基/緩沖液配制、清洗、滅菌，收獲生產(chǎn)，工衣清洗、滅菌、整理和分發(fā)在滿足安全操作和所有適用法規(guī)符合性的前提下，完成部門目標(biāo)和任務(wù)； 9.Participate in the internal auditing program for CBL as required. 根據(jù)需要，參與CBL內(nèi)部審計(jì)； 10.Assist MFG Manager in hosting regulatory or due diligence inspections. Act as SME to regulatory agencies. Oversee the timely response and follow-up to any observations. 協(xié)助生產(chǎn)經(jīng)理，接待監(jiān)管或盡職相關(guān)的檢查；作為監(jiān)管機(jī)構(gòu)的SME；督促針對(duì)各種觀察項(xiàng)的及時(shí)反饋和跟進(jìn)； 11.Train other technicians in group and individual settings on best practices and compliance to SOPs. 作為團(tuán)隊(duì)或個(gè)人講師，培訓(xùn)其他技術(shù)人員，使達(dá)到最優(yōu)的操作實(shí)踐和SOP依從性； 12.Determine GMP training requirements and curricula. Design and conduct, or outsource, training courses to enhance GMP knowledge level among company personnel. 決定GMP培訓(xùn)的要求和課程；為了提高公司員工的GMP知識(shí)水準(zhǔn)，設(shè)計(jì)、安排或外購(gòu)培訓(xùn)課程； 13.Serve as group representative on cross-functional teams. Communicate effectively and professionally. 在跨職能團(tuán)隊(duì)中，作為小組代表。高效、專業(yè)地溝通； 14.Anticipate potential problems and take preventative action. 能預(yù)見潛在的問(wèn)題，并采取預(yù)防性措施； 15.Apply appropriate PPE to complete all work to ensure compliance with the company EHS requirements. 應(yīng)用適當(dāng)?shù)膫€(gè)人防護(hù)用品去完成所有工作，確保符合公司環(huán)境健康安全的要求。