Quality Automation Specialist
Sai Kiran NaganiUnited StatesMIDPosted 10d ago
SeleniumToscaCSVGxPFDA 21 CFR Part 11EU GMP Annex 11GAMP 5
About the Role
We are looking for an experienced IT QA Testing Specialist with pharmaceutical industry experience to support IT quality governance, software testing, test automation, and system validation.
Key Responsibilities
• Develop and maintain IT quality governance frameworks, QA standards, and procedures.
• Create test strategies, test plans, test cases, and test scripts.
• Perform manual, functional, integration, and regression testing.
• Develop and execute automated test scripts using tools such as Selenium, Tosca, or similar tools.
• Perform Computer System Validation (CSV) for pharmaceutical IT systems.
• Prepare validation documents, test reports, and traceability matrices.
• Ensure compliance with GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 requirements.
• Identify and track defects and ensure timely resolution.
• Support audits, change control, and quality documentation activities.
• Work with IT, business, and quality teams to improve testing processes and ensure compliance.
Requirements
• Bachelor’s degree in Computer Science, IT, Engineering, Pharmacy, Life Sciences, or a related field.
• Minimum 5 years of experience in IT QA testing, preferably in the pharmaceutical industry.
• Hands-on experience in test strategy, test planning, test case creation, and execution.
• Experience in test automation and Computer System Validation (CSV).
• Knowledge of pharmaceutical regulations, GxP compliance, and data integrity.
• Experience with QA documentation, defect tracking, and audit support.