崗位職責(zé):
1.在臨床中試和放大項(xiàng)目中提供技術(shù)支持,尤其是需要應(yīng)用創(chuàng)新制造技術(shù)的制劑產(chǎn)品。
Provide technical support for clinic trial of pilot and commercial-scale, which requires the application of innovative manufacturing technologies, especially for DP.
2.負(fù)責(zé)設(shè)備性能確認(rèn)文件以及后續(xù)的驗(yàn)證工作
Be responsible for equipment PQ and following PPQ
3.主導(dǎo)工藝流程、方法以及設(shè)備的改進(jìn)
Lead or participate process improvement for process、method and equipment etc.
4.主導(dǎo)或參與產(chǎn)品技術(shù)轉(zhuǎn)移。
Lead or participate product technical transfer.
5.負(fù)責(zé)新產(chǎn)品的引入、技術(shù)轉(zhuǎn)移、撰寫方案以及批記錄、PPQ以及上市后商業(yè)化產(chǎn)品的生命周期管理
Be responsible for new product introduction、technology transfer、preparing protocol and BMR、following PPQ and managing product life cycle.
6.技術(shù)轉(zhuǎn)移以及后續(xù)生產(chǎn)過程中的異常問題處理。
Troubleshooting during technical transfer and subsequent manufacturing.
7.為其他部門人員提供技術(shù)培訓(xùn)和研討會,以促進(jìn)新制造技術(shù)的應(yīng)用。
Provides technical trainings and seminars to personnel of other departments to promote the application of new manufacturing technologies.
任職要求:
1. 本科以上學(xué)歷。
Bachelor degree or above
2. 英語口語、書寫熟練。
Fluent English in both oral and written
3. 1年或以上制藥行業(yè)工作經(jīng)驗(yàn)。
1 year or above working experience in pharmaceutical
4. 熟悉GMP和藥品生產(chǎn)管理要求。
Familiar with GMP and drug production management requirements
5. 熟悉口服固體制劑設(shè)備工藝/設(shè)備。
Familiar with process/equipment of oral solid drug