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)。