生產現場管理：
·
Improve, continuously review, and upgrade existing
production standard operating procedures and work systems and ensure their
strict implementation. 改進、持續審查和升級現有的生產標準操作規程和工作系統，并確保其嚴格執行。
·
Prepare and approve instructions related to
production operations, including in-process controls, and ensure their
implementation, if modified. 編制和批準與生產操作相關的指令，包括過程控制，并確保其執行（如有修改）。
·
Monitor on-line documentation and timely input of
all operations/activities. 監控所有操作/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/產品轉換過程中的清場。
·
Direct operators during production when discrepancies occur. 當出現差異時，在生產過程中直接指導操作員。
Train department personnel in initial (onboarding), on-the-job training, GMP, safety,sanitation, application, and production principles as needed. 根據需要對部門人員進行初步（入職）、在職培訓、GMP、安全、衛生、應用和生產原則方面的培訓。·
Inspect
the maintenance of the department, premises, and equipment. 檢查部門、場所和設備的維護情況。
·
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. 根據應用程序中提供的角色和權限操作智能軟件系統。
·
Processes/operates
the Cipdox software system according to the roles and rights provided in the
application. 根據應用程序中提供的角色和權限處理/操作Cipox軟件系統。
·
Process/operate
SAP system jobs according to the roles and rights provided in the application. 根據應用程序中提供的角色和權限處理/操作SAP系統作業。
Prepare and update
product history files, machine history files. 準備和更新產品歷史文件、機器歷史文件。·
Monitor
and control the production environment. 監控生產環境。
·
Strictly
comply with safety, health, and environmental regulations. 嚴格遵守安全、健康和環境法規。
·
Perform
risk analysis of products, systems, equipment, projects, and processes in
accordance with standard procedures. 根據標準程序對產品、系統、設備、項目和流程進行風險分析。
·
Complete,
evaluate, and sign all production records prior to providing them to Quality
Assurance. 在將所有生產記錄提供給質量保證部之前，完成、評估并簽署這些記錄。
·
Document
all changes through change control procedures in consultation with Quality
Assurance. 與質量保證部協商，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. 調查、記錄并向QA報告任何可能對材料/產品質量產生不利影響的問題，如容器損壞等。
·
Monitor
for compliance with cGMP requirements and investigate factors that may affect
product quality. 監測是否符合cGMP要求，并調查可能影響產品質量的因素。
·
Ensure
that cleaning procedures follow cGMP requirements and that they are strictly
enforced. 確保清潔程序符合cGMP要求并得到嚴格執行。
Record retention and
destruction. 記錄保存和銷毀。