? 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。
? IRM and CAPA Management
改進(jìn)和解決方案管理及糾正預(yù)防措施管理
? Review and release of Nonconformity reports are carried out in accordance with the specifications.
參照要求審核和批準(zhǔn)不符合報(bào)告。
? If necessary, review record occasionally from compliance point view,
如需要，不時(shí)的從合規(guī)角度審閱記錄。
? Any technical meetings are managed in accordance with the specifications.
參照要求管理技術(shù)會(huì)議。
? Perform final closure of CAPA cases in accordance with the specifications.
參照要求實(shí)施糾正預(yù)防錯(cuò)案例關(guān)閉。
? The local regulation requirements of the QMS are complied with during the implementation of the CAPA actions, amongst other things by means of a Q-review before the completion of CAPAs and a Q-review of quality notifications that are prepared in the course of CAPAs/product problems/ complaints.
在實(shí)施糾正預(yù)防措施行動(dòng)期間，要遵守質(zhì)量管理體系當(dāng)?shù)胤ㄒ?guī)要求，其中包括在糾正預(yù)防措施關(guān)閉之前進(jìn)行質(zhì)量審核以及質(zhì)量通知審核來源于糾正預(yù)防措施/產(chǎn)品問題/投訴。
? Other tasks assigned by line manager
完成直線經(jīng)理交辦的其他任務(wù)。
任職資格：
? Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
本科或研究生，生命科學(xué)，數(shù)據(jù)科學(xué)或其他相關(guān)/等同專業(yè)。
? Competent with routine application of MS Office能夠熟練使用MS office辦公軟件
? At least two (2) years in the Medical Device/Pharma/Biopharmaceutical industry
2年以上醫(yī)療器械，制藥或生物制藥企業(yè)
? Knowledge of the European, US, China and International cGMP regulations
熟悉歐洲，美國，中國和國際cGMP法規(guī)