職位描述
職位概述：
– 原液操作員需要按照現(xiàn)行GMP標(biāo)準(zhǔn)及生產(chǎn)標(biāo)準(zhǔn)操作規(guī)程的要求下，完成制劑原液的生產(chǎn)操作任務(wù)。
The DS operator is responsible for the execution of tasks needed to produce biopharmaceuticals under current "Good Manufacturing Practices" (cGMP) and in accordance with Standard Operating Procedures.
工作內(nèi)容：
– 在SOP的指導(dǎo)下，進(jìn)行原液的生產(chǎn)操作。包括但不限于以下生產(chǎn)活動(dòng)：培養(yǎng)基/緩沖液制備，細(xì)胞接種操作，生物反應(yīng)器操作，過(guò)濾設(shè)備操作，層析系統(tǒng)和超濾洗濾系統(tǒng)操作等。
Perform DS manufacturing under standard operation procedure, include but are not limited the following activity: Media/Buffer preparation, cell inoculum, bioreactor, filtration equipment, chromatography skids and UF/DF skid.
– 在SOP的指導(dǎo)下，能夠?qū)σ陨舷嚓P(guān)生產(chǎn)設(shè)備進(jìn)行清洗及簡(jiǎn)單的維護(hù)工作。
Perform the cleaning and maintenance procedure of related equipment under SOPs.
– 在生產(chǎn)主管的指導(dǎo)下，能夠協(xié)助編寫(xiě)標(biāo)準(zhǔn)生產(chǎn)規(guī)程。
Edits/write SOPs as directed by the production supervisor.
– 按照SOP要求進(jìn)行相應(yīng)的取樣操作及數(shù)據(jù)記錄。
Sampling and data recording based on SOPs.
– 按時(shí)完成被分配的培訓(xùn)項(xiàng)目并通過(guò)考核
Ensure to complete the training curricula on time and pass the learning assessment.
– 為保證新產(chǎn)品、新設(shè)備與新工藝順利實(shí)施，在他人指導(dǎo)下參與新產(chǎn)品試制和新設(shè)備的調(diào)試
Participate the new product technical transfer and new equipment IQ/OQ as directed by experienced stuff.
– 根據(jù)生產(chǎn)需要進(jìn)行倒班生產(chǎn)。
– Attend shift work according to manufacturing requirement.
任職要求：
教育程度/經(jīng)驗(yàn) Education/Experiences
– 高中以上學(xué)歷，藥劑/藥學(xué)相關(guān)專(zhuān)業(yè)。
At minimum high school diploma is required, Biotech/pharmacy/Chemistry or equivalent major.
– 有相關(guān)工作經(jīng)驗(yàn)者優(yōu)先。
Experience working in related environment is a plus.
特別知識(shí)/技能 Specific Knowledge & Skills
– 良好的口語(yǔ)和寫(xiě)作溝通能力、有一定的英語(yǔ)和計(jì)算機(jī)基礎(chǔ)知識(shí)、具有團(tuán)隊(duì)合作精神
Good oral and written communication skills are required. Skill of English and computer, a good team player
– 了解GMP相關(guān)知識(shí)者優(yōu)先。
Familiar with cGMP is a plus.
