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1. Responsible for aseptic product production site management, on-time completion of
product production tasks, to ensure that the product meets the quality standards.
負(fù)責(zé)無菌產(chǎn)品生產(chǎn)現(xiàn)場管理，按時完成產(chǎn)品生產(chǎn)任務(wù)，確保產(chǎn)品符合質(zhì)量標(biāo)準(zhǔn)。
2. Responsible for equipment qualification, process validation and cleaning validation in
production department scope, including protocol drafting, qualification/validation
executing, and report summarizing.
負(fù)責(zé)生產(chǎn)部門范圍內(nèi)的設(shè)備確認(rèn)、產(chǎn)品工藝驗證和清潔驗證，包括方案編寫、確認(rèn)/驗證執(zhí)
行和報告總結(jié)。
3. Responsible for SOPs/BPRs drafting and revising in production department scope,
responsible for staff training.
負(fù)責(zé)編寫和修訂生產(chǎn)部門范圍內(nèi)的SOP和BPR，負(fù)責(zé)員工培訓(xùn)工作。
4. Responsible for proceeding and following up on deviations, changes and CAPAs
related to the production department.
負(fù)責(zé)處理和跟進(jìn)與生產(chǎn)部門有關(guān)的偏差、變更和CAPA。
5. Responsible for safety management on production site, preventing accidents and
reporting safety risks and near miss events in a timely manner.
負(fù)責(zé)生產(chǎn)現(xiàn)場的安全管理，防止安全事故發(fā)生，及時報告安全風(fēng)險和安全隱患。
6. Complete other tasks as assigned by the superiors.
完成上級指派的其他任務(wù)。
任職要求：
1. Bachelor's degree with a major in pharmaceuticals and other related fields, 3 years’
experience in aseptic manufacturing. 2 years’ experience in people management.
本科學(xué)歷，主修制藥或其他相關(guān)專業(yè)，3年以上無菌制劑生產(chǎn)工作經(jīng)驗，2年以上的團(tuán)隊
管理經(jīng)驗。
2. Familiar with protocol preparing and implementing of sterile-related equipment
qualification, process validation and cleaning validation.
熟悉無菌制劑生產(chǎn)相關(guān)的設(shè)備確認(rèn)、產(chǎn)品工藝驗證和清潔驗證的方案編寫和執(zhí)行。
3. Experience with risk evaluation for aseptic manufacturing processes by common tools
and methods (RRF, FMEA, etc.).
能運用常用的風(fēng)險評估工具和方法（RRF、FMEA 等）對無菌生產(chǎn)環(huán)節(jié)進(jìn)行風(fēng)險評估。
4. Proficiency in Microsoft office software, Familiar with manufacturing process of sterile
liquid injections, experience in GMP related documents drafting/revising/training.
熟練掌握微軟辦公軟件，熟悉無菌液體注射劑的生產(chǎn)流程，具有編寫/修訂/培訓(xùn)GMP相關(guān)
文件的經(jīng)驗。
5. Familiar with the processes and requirements for quality system elements such as
deviations, changes and CAPAs in the pharmaceutical industry. Experience in deviation
investigations and change control implementation.
熟悉制藥行業(yè)質(zhì)量體系要素（如偏差、變更和CAPA）的流程和要求。具有偏差調(diào)查和變
更控制實施方面的經(jīng)驗。
6. High level of awareness of production safety and GMP aseptic behavior.
具備高度的安全生產(chǎn)和GMP無菌行為意識。
7. Good at English reading/writing skill, oral English is a plus.
良好的英語讀寫能力，具備英語口語能力更佳。