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生產(chǎn)現(xiàn)場管理：
·
Improve, continuously review, and upgrade existing
production standard operating procedures and work systems and ensure their
strict implementation. 改進、持續(xù)審查和升級現(xiàn)有的生產(chǎn)標(biāo)準(zhǔn)操作規(guī)程和工作系統(tǒng)，并確保其嚴(yán)格執(zhí)行。
·
Prepare and approve instructions related to
production operations, including in-process controls, and ensure their
implementation, if modified. 編制和批準(zhǔn)與生產(chǎn)操作相關(guān)的指令，包括過程控制，并確保其執(zhí)行（如有修改）。
·
Monitor on-line documentation and timely input of
all operations/activities. 監(jiān)控所有操作/活動的在線文檔和及時輸入。
·
Ensure line clean up during batch/product
changeover. 確保在批次/產(chǎn)品轉(zhuǎn)換過程中的清場。
·
Direct operators during production when discrepancies occur. 當(dāng)出現(xiàn)差異時，在生產(chǎn)過程中直接指導(dǎo)操作員。
Train department personnel in initial (onboarding), on-the-job training, GMP, safety,sanitation, application, and production principles as needed. 根據(jù)需要對部門人員進行初步（入職）、在職培訓(xùn)、GMP、安全、衛(wèi)生、應(yīng)用和生產(chǎn)原則方面的培訓(xùn)。·
Inspect
the maintenance of the department, premises, and equipment. 檢查部門、場所和設(shè)備的維護情況。
·
Ensure
that all verification, qualification and calibration are performed as planned
and records are maintained.確保所有驗證、鑒定和校準(zhǔn)按計劃進行，并保存記錄。
·
Operate
the Smart Track software system according to the roles and rights provided in
the application. 根據(jù)應(yīng)用程序中提供的角色和權(quán)限操作智能軟件系統(tǒng)。
·
Processes/operates
the Cipdox software system according to the roles and rights provided in the
application. 根據(jù)應(yīng)用程序中提供的角色和權(quán)限處理/操作Cipox軟件系統(tǒng)。
·
Process/operate
SAP system jobs according to the roles and rights provided in the application. 根據(jù)應(yīng)用程序中提供的角色和權(quán)限處理/操作SAP系統(tǒng)作業(yè)。
Prepare and update
product history files, machine history files. 準(zhǔn)備和更新產(chǎn)品歷史文件、機器歷史文件。·
Monitor
and control the production environment. 監(jiān)控生產(chǎn)環(huán)境。
·
Strictly
comply with safety, health, and environmental regulations. 嚴(yán)格遵守安全、健康和環(huán)境法規(guī)。
·
Perform
risk analysis of products, systems, equipment, projects, and processes in
accordance with standard procedures. 根據(jù)標(biāo)準(zhǔn)程序?qū)Ξa(chǎn)品、系統(tǒng)、設(shè)備、項目和流程進行風(fēng)險分析。
·
Complete,
evaluate, and sign all production records prior to providing them to Quality
Assurance. 在將所有生產(chǎn)記錄提供給質(zhì)量保證部之前，完成、評估并簽署這些記錄。
·
Document
all changes through change control procedures in consultation with Quality
Assurance. 與質(zhì)量保證部協(xié)商，通過變更控制程序記錄所有變更。
·
Investigate,
document & report to QA any issues that may adversely affect quality of the
material/product, such as damage to containers, etc. 調(diào)查、記錄并向QA報告任何可能對材料/產(chǎn)品質(zhì)量產(chǎn)生不利影響的問題，如容器損壞等。
·
Monitor
for compliance with cGMP requirements and investigate factors that may affect
product quality. 監(jiān)測是否符合cGMP要求，并調(diào)查可能影響產(chǎn)品質(zhì)量的因素。
·
Ensure
that cleaning procedures follow cGMP requirements and that they are strictly
enforced. 確保清潔程序符合cGMP要求并得到嚴(yán)格執(zhí)行。
Record retention and
destruction. 記錄保存和銷毀。