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(chǎng)管理，按時(shí)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(yàn)證和清潔驗(yàn)證，包括方案編寫、確認(rèn)/驗(yàn)證執(zhí)
行和報(bào)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(chǎng)的安全管理，防止安全事故發(fā)生，及時(shí)報(bào)告安全風(fēng)險(xiǎn)和安全隱患。
6. Complete other tasks as assigned by the superiors.
完成上級(jí)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(yàn)，2年以上的團(tuán)隊(duì)
管理經(jīng)驗(yàn)。
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(yàn)證和清潔驗(yàn)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(yùn)用常用的風(fēng)險(xiǎn)評(píng)估工具和方法（RRF、FMEA 等）對(duì)無菌生產(chǎn)環(huán)節(jié)進(jìn)行風(fēng)險(xiǎn)評(píng)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(yàn)。
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(shí)施方面的經(jīng)驗(yàn)。
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(shí)。
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。