微生物主管(J10338)-江苏招聘网

联系方式

联系人：方达医药技术（上海）有限公司-质量控制_CMC

联系电话：152****5633

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职位描述

岗位职责： 1.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。 2.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。 3.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。 4.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。 5.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。 6.Responsible for MDD investigation work. 负责MDD（微生物偏差调查）工作。 7.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。 8.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。 9.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。 10. Complete other tasks assigned by supervisors. 完成主管交办的其他任务。 11.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： 1.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。 2.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。 3. 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。 4. 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。 5. 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。