服務內容 Effectively producing intermediates and drug substances by operating complex processing equipment independently according to the Plant Master Procedure (i.e. PMP) in compliance with SOP, HSE, and other guidelines. 在符合SOP, HSE和其他規(guī)定的基礎上,按照工廠主操作規(guī)程,獨立操作復雜的工藝設備進行有效的醫(yī)藥中間體和最終產品的生產
1. Prepares equipment trains and other production variables according to the needs of the assigned process with little or no supervision. 能夠根據(jù)指定工藝流程的需要,基本可以獨立準備設備鏈和其他生產所需的事項 2. Executes the daily operations for the assigned process while following the PMP and maintaining compliance with SOP, HSE, and other guidelines 對指定工藝流程執(zhí)行日常操作,確保符合PMP,SOP,HSE以及其他相關規(guī)定 3. Can independently operate all routine process equipment and systems 能夠獨立操作所有常規(guī)生產設備和系統(tǒng) 4. Understands and carries out waste management activities in accordance with internal & external regulations (Exhaust air, effluent, liquid & solid waste) 根據(jù)內外部規(guī)章制度,了解并獨立進行廢棄物處理(廢氣,廢水,廢液和固廢) 5. Reassembles & cleans most process equipment with little or no supervision 基本可以獨立進行大部分設備的清洗和重置 6. Record all actions in batch record 在操作記錄本上及時記錄所有操作 7. Actively contributes to keeping the plant clean and properly maintained 積極參與并保持良好的車間維護和清潔 8. Provide equipment and process troubleshooting ideas 在設備和工藝出現(xiàn)問題時能提供解決建議 9. Provide process and safety improvement suggestions 提供工藝和安全改進建議 10. Gives guidance to less experienced operators regarding equipment set-up, batch execution activities, and equipment cleaning. 在設備準備,生產批次執(zhí)行和設備清潔方面,對新進員工提供指導 11. Can carry out assigned special tasks (e.g. process steering control analytics) 可以執(zhí)行特定的任務(如: 中控分析) 12. Can lead operating team as needed 如有需要,可以領導操作團隊 13. Various responsibilities in accordance to GMP HSE responsibility lists of the LSC 根據(jù)GMP/HSE要求,承擔其他相關職責