グローバルでサービスを展開する大手外資系ITサービス企業でのValidation Leader (System)の求人

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

【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