Validation Engineer (Life Science)
IN-TN-Chennai
English Portal
Req #: 37970
Type: Permanent or Fixed Term Contract
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Overview: * 10+ years' experience (Senior role) in computer system validation, preferably in Life Science. * Experience in process optimization in automated test environment. * Considerable knowledge of software development life cycle. * Experienced in serving as technical liaison between end users and tester * Proficient with 21 CFR Part 11, ICH guidelines, and FDA regulations on computer system valid * Excellent interpersonal, written, and verbal communication skills; flexible; works well on a team; strong problem-solving ability; good project management skills and excellent collaborative skill 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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