计算机系统验证经理

岗位职责：
1.Perform duties at the direction of the engineering manager.
在工程部经理的指导下履行职责

2.Ensure that all Validation/Engineering personnel are appropriately trained to complete computer system validation and maintenance.
确保所有验证/工程人员接受适当的培训以完成计算机系统验证和维护

3.Prepare, review, implement and maintain computer system Validation protocols.
制定、审核、执行和维护计算机系统验证方案

4.Prepare, review, implement and maintain computer system SOP for GMP applications.
制定、审核、执行和维护计算机系统标准操作规程以实施GMP业务

5.Prepare, review, implement and maintain computer system SOP’s for Non-GMP Business applications.
制定、审核、执行和维护计算机系统操作规程以实施非GMP业务

5.Prepare, review, implement and maintain computer system Policy’s form GMP and Non-GMP applications.
制定、审核、执行和维护实施GMP和非GMP的计算机系统方针表格

6.Assist with Validation execution on equipment and instruments.
协助完成设备和仪器验证

7.Assist with Validation of equipment computer systems.
协助完成设备计算机系统验证

8.Capture vendor training and set up training programs internally for operators.
为操作者获取供应商培训并建立内部培训项目

9.Assist with issues and provide guidance and training for computer system maintenance.
协助解决问题并为计算机系统的维护提供指导和培训

10.User management GMP computer systems.
GMP计算机系统的用户管理

11.User management Non-GMP Computer systems.
非GMP计算机系统的用户管理

12.Specify and find solutions for IT systems for GMP and Non-GMP applications

At the direction of the engineering manager assist with the management of all IT based systems.
规定并找到实施GMP和非GMP的IT系统的解决方案，在工程部经理的指导下，协助管理所有IT系统

13.As required participate in the Weekly Quality Organisation Meeting.

根据需要参加每周质量部会议。

14.As required participate in the Monthly Quality Organisation and Operations Organisation Meeting.

根据需要参加月度质量部和运营部会议。

15.As required participate in the Quarterly Management Review Meeting.

根据需要参加季度管理审核会议。

16.Update and maintain the Validation Master Plan for computer system requirements.

更新和维护计算机系统要求验证主计划。

17.In conjunction with Operations and in accordance with the Validation Master Plan prepare GAMP documentation for new equipment and systems.

与运营部协同按照验证主计划为新设备和系统制定GAMP文件。

18.In conjunction with Operations review supplier submitted documentation for new equipment and systems.

与运营部协同审核供应商提交的新设备和系统的文件。

19.In conjunction with Operations and in accordance with the Validation Master Plan prepare qualification and validation protocols for new equipment and systems.

与运营部协同按照验证主计划起草新设备和系统的确认和验证方案。

20.In conjunction with Operations execute qualification and validation protocols for new equipment and systems.

与运营部共同执行新设备和系统的确认和验证方案。

21.In conjunction with Operations document / resolve deviations identified when executing qualification and validation protocols for new equipment and systems.

与运营部共同记录/解决新设备和系统确认和验证方案执行中发现的偏差。

22.Prepare qualification summary reports for executed qualification and validation protocols for new equipment and systems.

为已执行确认和验证的新设备和系统起草确认总结报告。

23.In conjunction with Operations and in accordance with the Validation Master Plan prepare revalidation protocols for validated equipment and systems.

与运营部共同按照验证主计划为已验证的设备和系统起草再验证方案。

24.In conjunction with Operations execute revalidation protocols for validated equipment and systems.

与运营部共同执行设备和系统的再验证方案。

25.In conjunction with Operations document / resolve deviations identified when executing revalidation protocols for validated equipment and systems.

与运营部共同记录/解决在执行设备和系统的再验证方案过程中出现的偏差。

26.Prepare qualification summary reports for executed revalidation protocols for validated equipment and systems.

起草已执行再验证方案的设备和系统的确认总结报告。

27.Verify that all test equipment is in the appropriate calibrated state before use.

确认所有的检验设备在使用前已经过适当的校准。

28.Ensure that all test equipment is in the appropriate calibrated state before use.
确保所有的检验设备在使用前已经过适当的校准。

29.Notify the Manager of the QA Department immediately if a requirement of any qualification, validation or revalidation protocol fails to be met.

如果在确认、验证或再验证方案的执行过程中出现不符合情况，及时通知QA经理。

30.In conjunction with Operations maintain equipment and systems documents (including GAMP documents).

与运营部协同维护设备和系统文件（包括GAMP文件）。

31.Maintain the equipment and systems qualification, validation and revalidation documents.

保存设备和系统的确认、验证和再验证文件。

32.Maintain the equipment and systems qualification and validation document log.

1.Perform duties at the direction of the engineering manager.
在工程部经理的指导下履行职责

2.Ensure that all Validation/Engineering personnel are appropriately trained to complete computer system validation and maintenance.
确保所有验证/工程人员接受适当的培训以完成计算机系统验证和维护

3.Prepare, review, implement and maintain computer system Validation protocols.
制定、审核、执行和维护计算机系统验证方案

4.Prepare, review, implement and maintain computer system SOP for GMP applications.
制定、审核、执行和维护计算机系统标准操作规程以实施GMP业务

5.Prepare, review, implement and maintain computer system SOP’s for Non-GMP Business applications.
制定、审核、执行和维护计算机系统操作规程以实施非GMP业务

5.Prepare, review, implement and maintain computer system Policy’s form GMP and Non-GMP applications.
制定、审核、执行和维护实施GMP和非GMP的计算机系统方针表格

6.Assist with Validation execution on equipment and instruments.
协助完成设备和仪器验证

7.Assist with Validation of equipment computer systems.
协助完成设备计算机系统验证

8.Capture vendor training and set up training programs internally for operators.
为操作者获取供应商培训并建立内部培训项目

9.Assist with issues and provide guidance and training for computer system maintenance.
协助解决问题并为计算机系统的维护提供指导和培训

10.User management GMP computer systems.
GMP计算机系统的用户管理

11.User management Non-GMP Computer systems.
非GMP计算机系统的用户管理

12.Specify and find solutions for IT systems for GMP and Non-GMP applications

At the direction of the engineering manager assist with the management of all IT based systems.
规定并找到实施GMP和非GMP的IT系统的解决方案，在工程部经理的指导下，协助管理所有IT系统

13.As required participate in the Weekly Quality Organisation Meeting.

根据需要参加每周质量部会议。

14.As required participate in the Monthly Quality Organisation and Operations Organisation Meeting.

根据需要参加月度质量部和运营部会议。

15.As required participate in the Quarterly Management Review Meeting.

根据需要参加季度管理审核会议。

16.Update and maintain the Validation Master Plan for computer system requirements.

更新和维护计算机系统要求验证主计划。

17.In conjunction with Operations and in accordance with the Validation Master Plan prepare GAMP documentation for new equipment and systems.

与运营部协同按照验证主计划为新设备和系统制定GAMP文件。

18.In conjunction with Operations review supplier submitted documentation for new equipment and systems.

与运营部协同审核供应商提交的新设备和系统的文件。

19.In conjunction with Operations and in accordance with the Validation Master Plan prepare qualification and validation protocols for new equipment and systems.

与运营部协同按照验证主计划起草新设备和系统的确认和验证方案。

20.In conjunction with Operations execute qualification and validation protocols for new equipment and systems.

与运营部共同执行新设备和系统的确认和验证方案。

21.In conjunction with Operations document / resolve deviations identified when executing qualification and validation protocols for new equipment and systems.

与运营部共同记录/解决新设备和系统确认和验证方案执行中发现的偏差。

22.Prepare qualification summary reports for executed qualification and validation protocols for new equipment and systems.

为已执行确认和验证的新设备和系统起草确认总结报告。

23.In conjunction with Operations and in accordance with the Validation Master Plan prepare revalidation protocols for validated equipment and systems.

与运营部共同按照验证主计划为已验证的设备和系统起草再验证方案。

24.In conjunction with Operations execute revalidation protocols for validated equipment and systems.

与运营部共同执行设备和系统的再验证方案。

25.In conjunction with Operations document / resolve deviations identified when executing revalidation protocols for validated equipment and systems.

与运营部共同记录/解决在执行设备和系统的再验证方案过程中出现的偏差。

26.Prepare qualification summary reports for executed revalidation protocols for validated equipment and systems.

起草已执行再验证方案的设备和系统的确认总结报告。

27.Verify that all test equipment is in the appropriate calibrated state before use.

确认所有的检验设备在使用前已经过适当的校准。

28.Ensure that all test equipment is in the appropriate calibrated state before use.
确保所有的检验设备在使用前已经过适当的校准。

29.Notify the Manager of the QA Department immediately if a requirement of any qualification, validation or revalidation protocol fails to be met.

如果在确认、验证或再验证方案的执行过程中出现不符合情况，及时通知QA经理。

30.In conjunction with Operations maintain equipment and systems documents (including GAMP documents).

与运营部协同维护设备和系统文件（包括GAMP文件）。

31.Maintain the equipment and systems qualification, validation and revalidation documents.

保存设备和系统的确认、验证和再验证文件。

32.Maintain the equipment and systems qualification and validation document log.