職位描述
職位概述：
– 原液操作員需要按照現行GMP標準及生產標準操作規程的要求下，完成制劑原液的生產操作任務。
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.
工作內容：
– 在SOP的指導下，進行原液的生產操作。包括但不限于以下生產活動：培養基/緩沖液制備，細胞接種操作，生物反應器操作，過濾設備操作，層析系統和超濾洗濾系統操作等。
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的指導下，能夠對以上相關生產設備進行清洗及簡單的維護工作。
Perform the cleaning and maintenance procedure of related equipment under SOPs.
– 在生產主管的指導下，能夠協助編寫標準生產規程。
Edits/write SOPs as directed by the production supervisor.
– 按照SOP要求進行相應的取樣操作及數據記錄。
Sampling and data recording based on SOPs.
– 按時完成被分配的培訓項目并通過考核
Ensure to complete the training curricula on time and pass the learning assessment.
– 為保證新產品、新設備與新工藝順利實施，在他人指導下參與新產品試制和新設備的調試
Participate the new product technical transfer and new equipment IQ/OQ as directed by experienced stuff.
– 根據生產需要進行倒班生產。
– Attend shift work according to manufacturing requirement.
任職要求：
教育程度/經驗 Education/Experiences
– 高中以上學歷，藥劑/藥學相關專業。
At minimum high school diploma is required, Biotech/pharmacy/Chemistry or equivalent major.
– 有相關工作經驗者優先。
Experience working in related environment is a plus.
特別知識/技能 Specific Knowledge & Skills
– 良好的口語和寫作溝通能力、有一定的英語和計算機基礎知識、具有團隊合作精神
Good oral and written communication skills are required. Skill of English and computer, a good team player
– 了解GMP相關知識者優先。
Familiar with cGMP is a plus.
