招聘岗位:微生物检测(南京)
职位描述
KEY ACCOUNTIBILITIES:
1. Perform microbial test: method development, method validation and test of drug substances, products, raw materials.
1. 原料药,制剂,原辅料料等的微生物限度发放开发、验证
2. Monitor GMP clean area periodically according to the requirement of SOP.
2. 洁净区等监控,包括水系统,压缩空气系统,氮气系统,局部空气净化设备等,监控项,包括化学测试,沉降菌、浮游菌、表面检测和尘埃粒子等
3. Perform sample analysis including but not limited to GMP drug substances and products used for clinical trials.
3. 原料药、制剂等微生物限度测试
4. Manage the working organisms and the microbial lab cleaning.
4. 微生物洁净区管理、菌种管理
5. Assume responsibility for assigned instruments, maintaining them in proper calibration and working status according to the appropriate SOP; Perform IQ/OQ/PQ /PC as assigned.
5. 微生物相关仪器设备校验和维护,如IQ安装确认/OQ运行确认/PQ性能确认/PM性能维护/PC年度性能确认/CAL校验.
6. Write up IQ/OQ/PQ /PC protocols and/or protocol, method or report related to microbial testing.
6. IQ/OQ/PQ /PC相关材料书写
要求:
1. 微生物学, 药学或药物分析相关专业大专以上。
2. 有一年以上微生物检验及仪器分析的实际工作经验,有QC经验的优先。
3. 了解cGMP相关法规,熟悉各类药典(USP, EP 和ChP等)的微生物操作规程。
4. 有高度责任心,工作细致,认真负责,有较好的团队合作精神。
5. Must be customer-oriented and able to show flexibility and ability to work with multiple projects. Must be able to prioritize the workload to meet the pre-determined timelines.
6. Individuals will be expected to accomplish their work assignments by interacting closely with fellow scientists and by developing cooperative working relationships with other personnel inside the company.
7. Good communication, open exchange of information and project teamwork will be required in order to meet job performance.
8. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.