GXP tester

About Ascendion Ascendion is a leader in AI-Native platform driven software engineering company that underwrites outcomes, helping businesses innovate faster, smarter, and with greater impact. We partner with Global 2000 clients across North America, UK, Europe, and APAC to solve complex challenges in data, experience design, software product engineering, and workforce transformation. Powered by expert engineers, thousands of AI agents, and our Engineering to the Power of AI (EngineeringAI) method, we deliver measurable outcomes that build trust, unlock value, and accelerate growth. Learn more at ascendion.com Ascendion | Engineering to elevate life We have a culture built on opportunity, inclusion, and a spirit of partnership. Come, change the world with us: Build the coolest tech for worlds leading brands Solve complex problems and learn new skills Experience the power of transforming digital engineering for Fortune 500 clients Master your craft with leading training programs and hands-on experience Experience a community of change makers! Join a culture of high-performing innovators with endless ideas and a passion for tech. Our culture is the fabric of our company, and it is what makes us unique and diverse. The way we share ideas, learning, experiences, successes, and joy allows everyone to be their best at Ascendion. About the Role: We are seeking a GxP Tester with experience in validating regulated applications used within the Life Sciences, Pharmaceutical, or Healthcare industry. The candidate will be responsible for ensuring systems comply with regulatory requirements and internal quality standards through comprehensive testing and Computer System Validation (CSV) activities. Job Title: GxP TESTER Key Responsibilities: Plan, prepare, and execute validation activities for GxP-regulated applications. Review User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS). Develop and execute IQ, OQ, and PQ protocols. Prepare validation documentation, including Validation Plans, Traceability Matrices, and Validation Summary Reports. Design and execute functional, regression, integration, and User Acceptance Testing (UAT) test cases. Verify compliance with GxP regulations, GAMP 5, 21 CFR Part 11, and EU Annex 11. Perform risk assessments and support risk-based validation activities. Document test evidence and maintain complete validation records for audit readiness. Identify, log, and track defects, ensuring timely resolution with development and business teams. Support change control, deviation management, and CAPA activities. Collaborate with quality assurance, validation, business, and technical teams throughout the validation lifecycle. Participate in internal and external audits by providing validation documentation and evidence. Ensure all validation deliverables comply with organisational SOPs and regulatory requirements. Contribute to continuous improvement of validation and testing processes. Minimum Qualifications: Desired Qualifications (Optional): Location: PUNE/ GURGAON Want to change the world Let us know. Tell us about your experiences, education, and ambitions. Bring your knowledge, unique viewpoint, and creativity to the table. Lets talk! .