Job Description

Title: Computer System Validation
Location: Bangalore
Exp: 5 + Years (2+ years of Computer System Validation/ Product Software Validation testing experience
:

• 2+ years of Computer System Validation/ Product Software Validation testing experience in a regulated environment.
• Understanding of US FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and ISO regulations. e.g., design controls, risk management, and software validation.
• Prepare and manage key validation documents, including Validation Master Plans (VMP), risk assessments, protocols, test plans, and reports. Ensure that these documents are compliant with internal and external standards.
• Design, document, and execute detailed test cases that demonstrate that the system meets the validation requirements. This includes functional testing, integration testing, and user acceptance testing (UAT).

Skills Required