Senior QC Specialist _ Micro

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Job Description

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。

2负责执行实验室微生物限度及无菌检测，包括原料、中间品、产品和公共设施等的微生物检测和控制以及负责执行生产及实验室水系统、压缩空气、洁净区域环境监控工作。

3负责执行生物制品、微生物和无菌实验室实验仪器/设备日常清洁、维护，执行日常点检，保证仪器设备处于正常使用状态。

4负责执行生物制品、微生物和无菌相关法规及Global SOP的差距分析，分析方法差距分析、分析方法验证或微生物设备验证和确认。

5负责微生物实验室及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，包括采购、配制、保存及适用性检查。

6维护生物制品、微生物相关SOP、质量标准、检验记录等文件，参与和执行微生物相关的分析方法/流程优化等持续改进项目。

7执行新分析仪器的AIQ验证和计算机化系统回顾和升级等活动。

8遵守公司EHS的管理规定，严格执行实验室相关的化学品管理、个人防护用品、危险废弃报废等各项要求。

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.

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