COMPLETE Supervisor, Change & Risk Management, QA System - APAC, CN-42, Wuhan, CSL Behring

Provide strategic and business direction for the Change Control and Risk Management functions. Initiate actions designed to support and achieve site’s objectives.

为变更控制和风险管理职能提供战略和业务方向，并发起旨在支持和实现工厂目标的行动。

Manage all operational aspects of the Change Management System.  Ensure that GxP changes are processed, evaluated and appropriately documented in a timely manner.

管理变更管理系统的所有操作方面。确保GxP变更得到及时的处理、评估和适当的文档化。

Manage the Change Assessment Team (CAT) Meeting for the evaluation of process related changes.

管理变更小组以评估过程相关的变更。

Manage significant and complex changes related to process, facilities, materials, software, systems, and services with a GxP impact to ensure that changes are appropriate and comply with registered conditions.

管理与工艺、设施、物料、软件、系统和cGxP服务相关的重大和复杂的变更，并对cGxP产生影响，以确保变更是适当的并符合注册条件。

Review the GxP changes to ensure that changes are properly assessed and categorized, change actions are properly identified and changes are clearly documented.

审核变更，以确保变更被合理地评估和分级，行动项被合理地制定，以及变更被清晰描述。

Monitor and track change controls. Release or reject change actions as per completion status.

监控和跟踪变更控制。根据完成情况放行或退回变更行动。

Manage the business continuity of change control process.

管理变更控制流程的业务连续性。

Review change effectiveness check, approve the closure of change.

审核变更有效性核查，批准变更关闭。

Collect and report change control and risk management data to support Quality Reviews (e.g., QMR).

整理和报告变更控制和风险管理数据，以支持质量回顾(如质量管理评审)。

Support Product Release group with the timely management of change controls that are associated with product lots for release.

支持产品放行团队及时管理与放行产品批次相关的变更控制。

Advise relevant Quality Delegates and Managers on the requirements of the quality management systems with respect to change controls.

就变更控制方面的质量管理体系要求，向相关质量代表和经理提供建议。

Liaise closely with all key stakeholders to ensure timelines for change execution are met.

与所有关键利益相关者紧密联系，确保变更执行的时间限得到满足。

Provide technical and quality operations advice that is compliant to the quality change management system.

提供符合质量变更管理体系的技术和质量操作建议。

Delivery of DigiTrack Change Management Training, as required.

根据需要提供DigiTrack变更管理培训。

Establish and maintain Change Control Management and Risk Assessment Management procedures, including electronic system operation procedure.

建立和维护变更控制和风险管理程序，包括在电子系统中的操作程序。

Participate and support in risk management efforts as required to support the CSL business on behalf of the Quality Compliance and QA System team.

代表合规和QA体系团队参与支持CSL业务的风险管理工作。

Implement and support a compliant risk register.

实施并支持符合要求的风险登记。

Assess, control, communicate and review risk management efforts in line with current industry guidelines.

根据当前的行业指导方针，评估、控制、沟通和评审风险管理工作。

Manage the archiving process of documents related to change control and risk management to ensure data integrity.

管理变更控制和风险管理相关文件的规定过程，以保证数据可靠性。

Assist QA Compliance Manager to provide appropriate training and development to team staff, improve collaboration within and between groups, in order to complete relevant work in a timely/efficient manner.

协助合规经理对组内员工进行适当的培训和发展，改善组内和部门之间的合作，以便及时/高效地完成相应工作。

Take other tasks and duties as assigned by Line manager or department lead.

完成领导交办的其他工作。

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About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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