We are looking for an engineer who has experience in Validation deliverables and Defect Management
- Understanding of the purpose of validation.
- Understanding of the overall validation approach for a project.
- Understanding of IT processes and the lifecycle of IT systems.
- Advanced knowledge of all IT process interactions.
- Advanced knowledge of information technology areas and IT service principles.
- Familiarity with FDA regulations (such as 21 CFR 11), GxP, SOX, EudraLex (such as Annex 11), PIC/S, including electronic records and electronic signatures.
- Strong working knowledge of good documentation practices.
- Validation planning
- Review of Validation deliverables
- Defect Management
- Periodic Reviews.
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