生产现场管理：

·
Improve, continuously review, and upgrade existing
production standard operating procedures and work systems and ensure their
strict implementation. 改进、持续审查和升级现有的生产标准操作规程和工作系统，并确保其严格执行。

·
Prepare and approve instructions related to
production operations, including in-process controls, and ensure their
implementation, if modified. 编制和批准与生产操作相关的指令，包括过程控制，并确保其执行（如有修改）。

·
Monitor on-line documentation and timely input of
all operations/activities. 监控所有操作/活动的在线文档和及时输入。

·
Ensure line clean up during batch/product
changeover. 确保在批次/产品转换过程中的清场。

·
Direct operators during production when discrepancies occur. 当出现差异时，在生产过程中直接指导操作员。

Train department personnel in initial (onboarding), on-the-job training, GMP, safety,sanitation, application, and production principles as needed. 根据需要对部门人员进行初步（入职）、在职培训、GMP、安全、卫生、应用和生产原则方面的培训。

·
Inspect
the maintenance of the department, premises, and equipment. 检查部门、场所和设备的维护情况。

·
Ensure
that all verification, qualification and calibration are performed as planned
and records are maintained.确保所有验证、鉴定和校准按计划进行，并保存记录。

·
Operate
the Smart Track software system according to the roles and rights provided in
the application. 根据应用程序中提供的角色和权限操作智能软件系统。

·
Processes/operates
the Cipdox software system according to the roles and rights provided in the
application. 根据应用程序中提供的角色和权限处理/操作Cipox软件系统。

·
Process/operate
SAP system jobs according to the roles and rights provided in the application. 根据应用程序中提供的角色和权限处理/操作SAP系统作业。

Prepare and update
product history files, machine history files. 准备和更新产品历史文件、机器历史文件。

·
Monitor
and control the production environment. 监控生产环境。

·
Strictly
comply with safety, health, and environmental regulations. 严格遵守安全、健康和环境法规。

·
Perform
risk analysis of products, systems, equipment, projects, and processes in
accordance with standard procedures. 根据标准程序对产品、系统、设备、项目和流程进行风险分析。

·
Complete,
evaluate, and sign all production records prior to providing them to Quality
Assurance. 在将所有生产记录提供给质量保证部之前，完成、评估并签署这些记录。

·
Document
all changes through change control procedures in consultation with Quality
Assurance. 与质量保证部协商，通过变更控制程序记录所有变更。

·
Investigate,
document & report to QA any issues that may adversely affect quality of the
material/product, such as damage to containers, etc. 调查、记录并向QA报告任何可能对材料/产品质量产生不利影响的问题，如容器损坏等。

·
Monitor
for compliance with cGMP requirements and investigate factors that may affect
product quality. 监测是否符合cGMP要求，并调查可能影响产品质量的因素。

·
Ensure
that cleaning procedures follow cGMP requirements and that they are strictly
enforced. 确保清洁程序符合cGMP要求并得到严格执行。

Record retention and
destruction. 记录保存和销毁。