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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(zhǔn)以下確認(rèn)&驗(yàn)證文件：基于法規(guī)標(biāo)準(zhǔn)，在RDSZ質(zhì)量管理體系（QMS）內(nèi)的系統(tǒng)確認(rèn)/工藝設(shè)備確認(rèn)/計(jì)算機(jī)化系統(tǒng)驗(yàn)證/清潔驗(yàn)證/微生物殺滅驗(yàn)證/運(yùn)輸驗(yàn)證。
? Be responsible to support project qualification and validation activities
負(fù)責(zé)支持項(xiàng)目相關(guān)的確認(rèn)和驗(yàn)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(guó)、中國(guó)和國(guó)際法規(guī)要求，以及羅氏GSP或集團(tuán)質(zhì)量標(biāo)準(zhǔn)。
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(jīng)理的有限協(xié)助下完成工作，以實(shí)現(xiàn)Q&R目標(biāo)和任務(wù)。能夠在直線經(jīng)理的協(xié)助下識(shí)別改進(jìn)并實(shí)施。應(yīng)用多元化的技能解決各種復(fù)雜情況。
? Identify and escalate issues as they arise; able to provide solutions.
能夠識(shí)別并匯報(bào)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(jiān)管下正確完成每日計(jì)劃內(nèi)和計(jì)劃外的任務(wù)。獨(dú)立地完成日常事務(wù)。有做決定的勇氣，即使是職責(zé)外或舒適區(qū)外的。果斷并且對(duì)于所作的決定沒有耽擱，開發(fā)解決方法，并且向直線經(jīng)理同時(shí)展示問題和解決方案。
Main Tasks & Responsibilities主要工作職責(zé)
? Qualification and Validation/Change Control
驗(yàn)證確認(rèn)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(jù)各項(xiàng)醫(yī)療器械法規(guī)（e.g GMP, ISO 13485）要求規(guī)劃及檢查/放行系統(tǒng)確認(rèn)。
? 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(jù)規(guī)范與用戶部門共同執(zhí)行確認(rèn)及驗(yàn)證活動(dòng)，且在規(guī)定時(shí)間內(nèi)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(guān)確認(rèn)/驗(yàn)證問題的咨詢，并支持確認(rèn)/驗(yàn)證的實(shí)施。
? Facilitate the qualification/validation related workshops to ensure compliance understanding from participants.
支持確認(rèn)/驗(yàn)證相關(guān)研討會(huì)，以確保參與者理解合規(guī)要求。
? Concepts for the qualification of systems and equipment are described and implemented jointly with the responsible site functions.
與負(fù)責(zé)的職能部門共同描述并實(shí)施系統(tǒng)和設(shè)備確認(rèn)概念。
? The valid status is maintained as per the control and follow-up of periodic reviews.
根據(jù)定期回顧的控制措施和跟蹤行動(dòng)維護(hù)驗(yàn)證狀態(tài)。
? Support Non-conformity report initiated during qualification/validation.
支持確認(rèn)/驗(yàn)證期間發(fā)起的不符合調(diào)查。
? Quality Review of change initiated in responsible areas, focus on validation/qualification task accuracy.
負(fù)責(zé)區(qū)域相關(guān)變更的質(zhì)量審核, 關(guān)注驗(yàn)證/確認(rèn)任務(wù)的準(zhǔn)確性。