Validation Engineer / CSV Engineer

Responsibilities :

• Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
• Ensure adherence to regulatory standards (FDA, ISO , IEC ) and industry best practices for non-product software.
• Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
• Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and CFR Part .
• Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional Plan.)
• Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
• Traceability Matrix.
• Periodic Reviews.
• System Retirement / Decommissioning.
• Execution of Dry / Test protocol run.
• Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
• Perform System Retirement / Decommissioning of systems not in business.
• Work closely with software development and IT teams to establish best practices for quality and compliance.
• Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
• Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.

Requirements :