Overview總覽
? 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.
審核/批準以下確認&驗證文件：基于法規標準，在RDSZ質量管理體系（QMS）內的系統確認/工藝設備確認/計算機化系統驗證/清潔驗證/微生物殺滅驗證/運輸驗證。
? Be responsible to support project qualification and validation activities
負責支持項目相關的確認和驗證工作
? 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.
確保流程符合歐洲、美國、中國和國際法規要求，以及羅氏GSP或集團質量標準。
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.
能夠在直線經理的有限協助下完成工作，以實現Q&R目標和任務。能夠在直線經理的協助下識別改進并實施。應用多元化的技能解決各種復雜情況。
? Identify and escalate issues as they arise; able to provide solutions.
能夠識別并匯報問題，提供解決方案。
? 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.
有能力在最小程度監管下正確完成每日計劃內和計劃外的任務。獨立地完成日常事務。有做決定的勇氣，即使是職責外或舒適區外的。果斷并且對于所作的決定沒有耽擱，開發解決方法，并且向直線經理同時展示問題和解決方案。
Main Tasks & Responsibilities主要工作職責
? Qualification and Validation/Change Control
驗證確認和變更控制
? Qualifications are planned and checked / released in compliance with regulation requirements (e.g China Medical device GMP, and ISO 13485).
根據各項醫療器械法規（e.g GMP, ISO 13485）要求規劃及檢查/放行系統確認。
? 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.
根據規范與用戶部門共同執行確認及驗證活動，且在規定時間內處理并形成文件。
? Provide consultancy to all functional units regard to qualification/validation queries and support the qualification/validation implementation.
向所有職能部門提供有關確認/驗證問題的咨詢，并支持確認/驗證的實施。
? Facilitate the qualification/validation related workshops to ensure compliance understanding from participants.
支持確認/驗證相關研討會，以確保參與者理解合規要求。
? Concepts for the qualification of systems and equipment are described and implemented jointly with the responsible site functions.
與負責的職能部門共同描述并實施系統和設備確認概念。
? The valid status is maintained as per the control and follow-up of periodic reviews.
根據定期回顧的控制措施和跟蹤行動維護驗證狀態。
? Support Non-conformity report initiated during qualification/validation.
支持確認/驗證期間發起的不符合調查。
? Quality Review of change initiated in responsible areas, focus on validation/qualification task accuracy.
負責區域相關變更的質量審核, 關注驗證/確認任務的準確性。