Overview总览
• Review/approval qualification & validation documents in the area: system qualifications / process equipment qualifications / computerized system validations / cleaning validations / germ reduction validations / transportation validations within the RDSZ Quality Management System (QMS) on the basis of regulatory standards.
审核/批准以下确认&验证文件：基于法规标准，在RDSZ质量管理体系（QMS）内的系统确认/工艺设备确认/计算机化系统验证/清洁验证/微生物杀灭验证/运输验证。
• Be responsible to support project qualification and validation activities
负责支持项目相关的确认和验证工作
• Ensure that the process is complies with the requirements of European, US, China and International cGMP regulations and the requirements from Roche Global Standard Process or Divisional Quality Standard.
确保流程符合欧洲、美国、中国和国际法规要求，以及罗氏GSP或集团质量标准。

The What做什么
• Perform activities as required to meet Q&R goals and objectives with minimal collaboration with supervisor. Able to identify improvements and implement with collaboration from supervisor. Navigates in complex situations by applying a diverse skillset.
能够在直线经理的有限协助下完成工作，以实现Q&R目标和任务。能够在直线经理的协助下识别改进并实施。应用多元化的技能解决各种复杂情况。
• Identify and escalate issues as they arise; able to provide solutions.
能够识别并汇报问题，提供解决方案。
• Ability to work day to day with minimal supervision to correctly complete daily scheduled and unscheduled activities. Initiates daily activities independently. Has courage to make decisions even outside of scope/comfort zone. Is decisive and does not procrastinate on decisions; develop solutions and presents both issues and solutions to supervisor.
有能力在最小程度监管下正确完成每日计划内和计划外的任务。独立地完成日常事务。有做决定的勇气，即使是职责外或舒适区外的。果断并且对于所作的决定没有耽搁，开发解决方法，并且向直线经理同时展示问题和解决方案。

Main Tasks & Responsibilities主要工作职责
 Qualification and Validation/Change Control
验证确认和变更控制
• Qualifications are planned and checked / released in compliance with regulation requirements (e.g China Medical device GMP, and ISO 13485).
根据各项医疗器械法规（e.g GMP, ISO 13485）要求规划及检查/放行系统确认。
• The qualification and validation activities are performed together with the owner departments in accordance with the specifications as well as being processed in due time and documented.
根据规范与用户部门共同执行确认及验证活动，且在规定时间内处理并形成文件。
• Provide consultancy to all functional units regard to qualification/validation queries and support the qualification/validation implementation.
向所有职能部门提供有关确认/验证问题的咨询，并支持确认/验证的实施。
• Facilitate the qualification/validation related workshops to ensure compliance understanding from participants.
支持确认/验证相关研讨会，以确保参与者理解合规要求。
• Concepts for the qualification of systems and equipment are described and implemented jointly with the responsible site functions.
与负责的职能部门共同描述并实施系统和设备确认概念。
• The valid status is maintained as per the control and follow-up of periodic reviews.
根据定期回顾的控制措施和跟踪行动维护验证状态。
• Support Non-conformity report initiated during qualification/validation.
支持确认/验证期间发起的不符合调查。
• Quality Review of change initiated in responsible areas, focus on validation/qualification task accuracy.
负责区域相关变更的质量审核, 关注验证/确认任务的准确性。