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Validation Leader (System)

年収:800万 ~ 1000万

ヘッドハンター案件

部署・役職名 Validation Leader (System)
職種
業種
勤務地
仕事内容 職務内容 . Project Management, Knowledge on GxP and Computer System Validation (CSV) , Customer SOP, aware of SDLC and deliverables, – Associated experience in pharmaceutical R&D domain would have an added advantage
. Excellent communication skill and exposure on handling customers at onsite. Ability to work as a team player in a consulting environment.
. Candidate must be aware of SDLC and deliverables- should be able to provide overall SDLC guidance and support
. Ensure that the project deliveries are in line with Customer SOP and quality framework
. Reviews requirements and functional solution and defines the SDLC/validation strategy
. Leads the relevant SDLC activities as defined in the validation plan. Ensures SDLC deliverables are accurate and appropriately approved
. Actively audit projects and systems to ensure that the appropriate validation activities are carried out in compliance with regulatory requirements and corporate standards
. Ensures the validation and testing activities are appropriately delivered
. Should have knowledge of Risk Management framework, mitigation and contingency plans, risk treatment options
応募資格

【歓迎(WANT)】

登録資格 【必須】
Must have worked in the CSV role for more than 5 years
Must have knowledge of the SDLC processes
Must have worked in Pharma Industry for more than 5 years
Must have knowledge of Testing Processes
Either have education or working knowledge of Pharma domain

【歓迎】
Worked with European and US customers

更新日 2020/12/16
求人番号 1596165

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