微生物分析主管

该职位来源于猎聘 岗位职责：

• Responsible for the daily management and personnel training of the microbiology laboratory, and for optimizing existing laboratory management procedures. 负责微生物实验室的日常管理和人员培训，并优化现有实验室管理程序。
• Prepare and review SOPs, documents related to microbiology laboratory activities. 准备并审核SOP及微生物实验室活动相关文件。
• Manage the environment, instruments, and equipment of the microbiology laboratory, including equipment maintenance and validation.

管理微生物实验室的环境、仪器和设备，包括设备维护与验证。

• Responsible for microbiological methods development, verification or validation according to client requirements.根据客户要求负责微生物方法的开发、确认或验证。
• Responsible for the management of environmental monitoring, raw materials, intermediates, finished products, process water, and other samples testing. equipment maintenance and validation. 负责环境监测、原料、中间体、成品、工艺用水及其他样品检测的管理。设备维护与验证。
• Responsible for MDD investigation work. 负责MDD（微生物偏差调查）工作。
• Participate in the validation of facilities, equipment, and various production processes. requirements.

参与设施、设备及各种生产工艺的验证。要求。

• Coordinate with different departments to undertake projects and ensure timely completion. 与不同部门协调，承接项目并确保按时完成。
• Participate in internal and external audits to ensure compliance in microbiological testing and laboratory management. 参与内部和外部审计，确保微生物检测和实验室管理符合规范。
• Complete other tasks assigned by supervisors. 完成主管交办的其他任务。
• Participate in internal and external audits to ensure compliance in microbiological testing and laboratory management. 参与内部和外部审计，确保微生物检测和实验室管理符合规范。 任职要求：
• Bachelor's degree or above in Biopharmaceuticals, Microbiology, or other related fields, with at least 5 years of GMP pharmaceutical microbiology testing and validation experience, including at least 2 years of microbiology laboratory management experience. 生物制药、微生物学及其他相关专业，本科以上学历，至少5年以上GMP药厂微生物检验和验证工作经验，至少2年以上微生物实验室管理经验。
• Familiar with GMP regulations, registration-related regulations and guidelines, change control, OOS/MDD, deviation investigation procedures, as well as the Chinese Pharmacopoeia and United States Pharmacopoeia.

熟悉GMP法规，注册相关法规和指南，变更、OOS/MDD和偏差调查程序以及中国药典和美国药典。

• Proficient in microbiological method validation and skilled in various pharmaceutical microbiological testing techniques, including sterility, microbial limits, endotoxin testing, antimicrobial effectiveness testing, and microbial culture maintenance. 熟悉微生物方法学验证，对药品微生物各项检测熟练，包括无菌、微生物限度、内毒素、抑菌效力、菌种传代管理等。
• Have good English reading and writing skills, with excellent communication and teamwork capabilities. 良好的英文阅读和写作能力，具有良好沟通能力和团队合作能力。
• Honest, dedicated, meticulous in work, with strong strategic thinking and a high sense of responsibility. 诚实，敬业，工作严谨，并具有良好的大局观和高度的责任心。