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Job Responsibilities 工作職責(zé)：
1.Responsible for process development of liquid / lyophilization / PFS filling processes, including but not limited to mixing stress, filling speed, pump stress, holding time study etc.
負責(zé)液體/凍干/預(yù)灌封的灌裝工藝開發(fā)，包括但不限于攪拌應(yīng)力、灌裝速度、泵應(yīng)力、保持時間等；
2.According to the process of Sending Unit, complete process transfer and scale-up at different scale at different site, and transfer the process to the manufacturing department finally.
按照轉(zhuǎn)移方轉(zhuǎn)移的工藝，完成不同廠區(qū)不同規(guī)模的工藝轉(zhuǎn)移和放大，并最終將工藝轉(zhuǎn)移到生產(chǎn)部門；
3.Responsible for PC/PV of liquid/lyophilization/PFS filling processes, including to SDM, PC/PPQ protocol, DOE, E/L assessment, sterile filtration validation, etc.
負責(zé)液體/凍干/預(yù)灌封的灌裝工藝表征和工藝驗證，包括但不限于縮小模型，工藝表征/工藝性能確認方案，實驗設(shè)計，可提取物和可浸出物評估，無菌過濾驗證等；
4.Responsible for managing technical documents including operating procedures, protocols, reports, risk assessments, laboratory investigations, etc.
負責(zé)管理技術(shù)文件包括操作規(guī)程，方案，報告，風(fēng)險評估，實驗室調(diào)查報告等；
5.Responsible for data analysis, data review and trend analysis.
負責(zé)數(shù)據(jù)分析，數(shù)據(jù)審核和趨勢分析；
6.Track the DP daily production and provide technology support for production of MFG, assist in troubleshooting and solving problems.
跟蹤DP的日常生產(chǎn)，并對MFG的生產(chǎn)提供技術(shù)支持，并協(xié)助排查與解決問題；
7.According to the production process, review the relevant GMP production documents.
根據(jù)生產(chǎn)工藝，審閱相關(guān)GMP生產(chǎn)文件；
8.Summary change control of owner each project, Optimize and improve processes, improve efficiency.
總結(jié)每個項目的變更控制，并優(yōu)化和改善工藝，提高效率；
9.Together with FD, pay attention to the information of related review and application regulations.
與FD一起關(guān)注相關(guān)評審和法規(guī)相關(guān)的信息；
10.Communicate effectively with the company’s internal and external departments to successfully complete the project on time.
與公司內(nèi)外各部門進行有效溝通，順利推動項目按時完成；
11.Other work arranged by superior leaders.
上級領(lǐng)導(dǎo)安排的其他工作。