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驗證經(jīng)理崗位職責(zé)：

提供藥品生產(chǎn)驗證咨詢（廠房/設(shè)施/設(shè)備/工藝等）；
Consulting for Pharmaceutical plant Validation(Premises/facility/equipment/process etc)

負(fù)責(zé)組織藥廠驗證活動的計劃和實施（包括建造期間的IO/PQ確認(rèn)活動和生產(chǎn)期間的驗證活動）
Responsible for validation consulting planning and execution (including IO/PQ and process validation)

參與驗證咨詢和服務(wù)銷售支持活動
Participating validation consulting and service sales support.

負(fù)責(zé)根據(jù)客戶產(chǎn)品和工藝編制/審核驗證咨詢文件、培訓(xùn)和指導(dǎo)客戶驗證活動實施；
Preparing/Review validation consulting documents; training and directing client implementation.



專業(yè)技能及經(jīng)驗要求

JOB KNOWLEDGE SKILLS AND EXPERIENCE

8年以上藥廠或制藥工程驗證或QA工作經(jīng)驗
Over eight years work experience include validation or QA in Pharmaceutical plants or Pharmaceutical Engineering fields

熟悉藥品生產(chǎn)驗證相關(guān)法規(guī)和指南（EU, USA, WHO, PIC/S, ISPE and ICH）
Familiar with the relevant regulations/guidelines of the pharmaceutical manufacturing practice and validation of EU, USA, WHO, PIC/S, ISPE and ICH.

本科以上學(xué)歷


At least bachelor degree majoring in Pharmaceutical or Engineering.

英語熟練
Good English Skills

能經(jīng)常出差
Business trip in China is preferred.