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| 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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