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1负责生物制品试验用试剂、试液、耗材、培养基、细胞培养物等的管理，包括新建管理体系和管理流程。和相关供应商及武田总部合作确保生物制品检验所用上述试验物品能够准确、及时的提供给药检所。
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1 be responsible for the management of reagents, test solutions, consumables, culture media, cell cultures, etc. for the test of biological products, including the establishment of a new management system and management process. Cooperate with relevant suppliers and Takeda headquarters to ensure that the above test items used by the laboratory for biological products can be accurately and timely provided to the Institute for drug control.
2 responsible for the implementation of laboratory microbial limit and sterility testing, including microbial testing and control of raw materials, intermediate products, products and public facilities, as well as the implementation of environmental monitoring of production and laboratory water system, compressed air and clean area.
3 be responsible for the daily cleaning and maintenance of laboratory instruments/equipment for biological products, microorganisms and sterility, and the daily spot inspection to ensure that the instruments and equipment are in normal use.
4 be responsible for the implementation of gap analysis of relevant regulations on biological products, microbiology and sterility and global SOP, gap analysis of analytical methods, validation of analytical methods or validation and validation of microbial equipment.
5 be responsible for the management of reagents, test solutions, consumables, culture media, cell cultures, etc. for microbiological laboratory and biological products test, including procurement, preparation, preservation and applicability inspection.
6 maintain biological products, microbiological related SOPs, quality standards, inspection records and other documents, and participate in and implement continuous improvement projects such as microbiological related analysis methods/process optimization.
7 carry out AIQ verification of new analytical instruments and computerized system review and upgrade.
8 comply with the company's EHS management regulations, and strictly implement the requirements of laboratory related chemicals management, personal protective equipment, hazardous waste disposal, etc.
Tianjin, China
Employee
Regular
Full time
We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society.
We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.
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