Validation Engineer

3 days ago


chennai, India Expleo Full time

Responsibilities

Planning and leading validation and qualification activities for multiple complex projects of any size, which may be regional or global in scope and are occurring at the same time. Ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by client and the FDA. Coordinating multiple validation and qualification activities with project teams, various departments, and external vendors. System Testing, Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control. Conducting meetings for Risk Impact Assessments (RIA), Validation Risk Assessments and 21 CFR Part 11 Asse Creating User Requirements Specifications and assisting in the creation of a Functional Requirements Specification and the Technical Design Specification. Creating all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer. Reviewing all System Delivery Life Cycle (SDLC) deliverables, providing constructive feedback, and ensuring that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs). Conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time. Create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11, to Client person Representing Validation Services during sponsor audits and conducting external vendor a Focus on meeting project schedules, conducting System Delivery Lifecyle (and Agile SDLC), Validation,
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