BE degree or equivalent work experience in Computer Science, Biology, Biomedical or related field.
Over all 5+ Years of experience and at least 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).
Record, report, and verify software defects to accurately depict the software requirements also work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects.
Create change orders in document control system. Conduct test design reviews and risk assessments with core team members, influences key stakeholders to drive quality improvements.
Participate in product validation to ensure the software meets user needs requirements of user workflows for a regulated environment.
