招聘崗位:微生物檢測(cè)(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(fā)放開(kāi)發(fā)、驗(yàn)證
2. Monitor GMP clean area periodically according to the requirement of SOP.
2. 潔凈區(qū)等監(jiān)控,包括水系統(tǒng),壓縮空氣系統(tǒng),氮?dú)庀到y(tǒng),局部空氣凈化設(shè)備等,監(jiān)控項(xiàng),包括化學(xué)測(cè)試,沉降菌、浮游菌、表面檢測(cè)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(cè)試
4. Manage the working organisms and the microbial lab cleaning.
4. 微生物潔凈區(qū)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(guān)儀器設(shè)備校驗(yàn)和維護(hù),如IQ安裝確認(rèn)/OQ運(yùn)行確認(rèn)/PQ性能確認(rèn)/PM性能維護(hù)/PC年度性能確認(rèn)/CAL校驗(yàn).
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(guān)材料書(shū)寫(xiě)
要求:
1. 微生物學(xué), 藥學(xué)或藥物分析相關(guān)專業(yè)大專以上。
2. 有一年以上微生物檢驗(yàn)及儀器分析的實(shí)際工作經(jīng)驗(yàn),有QC經(jīng)驗(yàn)的優(yōu)先。
3. 了解cGMP相關(guān)法規(guī),熟悉各類藥典(USP, EP 和ChP等)的微生物操作規(guī)程。
4. 有高度責(zé)任心,工作細(xì)致,認(rèn)真負(fù)責(zé),有較好的團(tuán)隊(duì)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.