招聘崗位:微生物檢測(南京)
職位描述
KEY ACCOUNTIBILITIES:
1. Perform microbial test: method development, method validation and test of drug substances, products, raw materials.
1. 原料藥,制劑,原輔料料等的微生物限度發放開發、驗證
2. Monitor GMP clean area periodically according to the requirement of SOP.
2. 潔凈區等監控,包括水系統,壓縮空氣系統,氮氣系統,局部空氣凈化設備等,監控項,包括化學測試,沉降菌、浮游菌、表面檢測和塵埃粒子等
3. Perform sample analysis including but not limited to GMP drug substances and products used for clinical trials.
3. 原料藥、制劑等微生物限度測試
4. Manage the working organisms and the microbial lab cleaning.
4. 微生物潔凈區管理、菌種管理
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. 微生物相關儀器設備校驗和維護,如IQ安裝確認/OQ運行確認/PQ性能確認/PM性能維護/PC年度性能確認/CAL校驗.
6. Write up IQ/OQ/PQ /PC protocols and/or protocol, method or report related to microbial testing.
6. IQ/OQ/PQ /PC相關材料書寫
要求:
1. 微生物學, 藥學或藥物分析相關專業大專以上。
2. 有一年以上微生物檢驗及儀器分析的實際工作經驗,有QC經驗的優先。
3. 了解cGMP相關法規,熟悉各類藥典(USP, EP 和ChP等)的微生物操作規程。
4. 有高度責任心,工作細致,認真負責,有較好的團隊合作精神。
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.