• 招聘类型：社招
• 工作性质：全职
• 所属区域：广州 - 工厂
• 直属部门：QC

职位描述

1. Asist manager for micro-lab routine management

协助上级主管进行微生物实验室的日常管理

2. New technology and equipment introduce/microbial related test methods development/t transformation

新技术/设备/方法的开发及转移

3. New technology and equipment introduce/microbial related test methods development/t transformation

负责文件及记录审核，确保实验室检验数据的完整性及法规符合性

4. Analysis and trend interpretation of microbiological abnormal data, formulate the corresponding solutions to achieve effective prevention of adverse events

异常数据分析及趋势解读，制定相应的解决方案，实现不良事件的有效预防

5. Micro-lab routine GMP self-inspection

负责微生物实验室日常的符合性自检

6. Support LIMS system and other automation systems operation and maintenance

支持LIMS系统及其他自动化系统的运行及维护

7. Support manufacturing department for microbial related assessment and control, including but not limited to Change Control, CAPA, Non-compliance and Risk Assessment

支持生产部门与微生物控制相关的评估及决策，包括但不限于变更、预防纠正措施、偏差及风险评估等

任职条件

1.Bachelor or above degree on Pharmacy, Microbial, Biotechnical, etc

本科及以上学历，药学，微生物学或生物技术相关专业

2.Familiar with the ChP/USP/EP and the GMP/cGMP/EU GMP

熟悉中国药典、美国药典、欧洲药典及GMP/cGMP/欧盟GMP的相关要求

3.Familiar with the principle and development/transformation of sterility test/microbiology limit test/endotoxin test

熟悉无菌检查、微生物限度检查、细菌内毒素检查等药品微生物检查方法的原理及开发/转移

4.Familiar with the principles and management of common equipment such as endotoxin testing equipment, isolator, autoclave, ID detector, etc

熟练掌握细菌内毒素检测仪器、无菌检查隔离器、脉动真空灭菌柜、微生物鉴定仪等常用设备的原理及管理

5.Familiar with the analysis and trend interpretation of microbiological abnormal data, and able to propose scientific and compliant solutions

熟悉微生物异常数据的分析及趋势解读，并能提出科学、合规的解决方案

6.Familiar with microbial contamination control of sterile product

熟悉无菌药品生产微生物控制要求

职位要求

• 学历要求：本科
• 工作经验：3年
• 外语要求：不需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日