About Apexon Apexon is a digital-first technology services firm that accelerates business transformation and delivers human-centric digital experiences. We partner with clients across their digital journey, helping them outperform their competition through speed and innovation. Our core competencies span across AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering, and UX. With deep domain expertise in BFSI, healthcare, and life sciences, we help organizations unlock the full potential of digital. Backed by Goldman Sachs Asset Management and Everstone Capital, Apexon operates across 15 global offices and 10 delivery centers on four continents.We enable #HumanFirstDIGITAL.Job Title: Manual + Computer System Validation Lead Location: Bangalore (Hybrid) Joining Timeline: Immediate to 30 Days Experience Required: 8+ Years (including 2–3 years in a lead role)Job Summary: We are looking for a Validation Lead with strong experience in manual testing, validation strategy, and documentation. This role involves leading validation efforts while also contributing individually to project delivery. The ideal candidate will bring deep quality assurance expertise, especially within regulated environments, and have a proactive, hands-on approach to leading teams and driving excellence.Key Responsibilities Lead and manage validation/testing efforts for critical programs in an Agile environment. Develop and review key test documentation: Test Plans, RTMs, Test Strategies, Test Data, Bug Reports, and Test Execution Reports. Design, execute, and maintain test cases; track and resolve defects efficiently. Guide and mentor team members in validation best practices and documentation standards. Collaborate with cross-functional teams to ensure quality deliverables. Leverage test management tools like JIRA and ALM for documentation and defect lifecycle tracking. Perform various manual testing techniques including Functional, Regression, and System Testing. Conduct database testing and validate backend integrity using SQL. Ensure compliance with applicable validation standards and regulatory guidelines.Required Skills & Qualifications Minimum 8+ years of QA/Validation experience, with 2–3 years in a lead capacity. Familiarity with 21 CFR Part 11 or similar regulatory frameworks. Deep expertise in manual testing, test design, and documentation. Strong understanding of defect management, prioritization (Severity vs. Priority), and triage processes. Proficient in JIRA and ALM for test and defect tracking. Hands-on experience with Agile/Scrum methodologies. Working knowledge of Database Testing and SQL. Domain experience in Life Sciences, Healthcare, or Clinical Trials.Additional Attributes Proven ability to balance leadership responsibilities with individual contributions. Excellent communication, documentation, and stakeholder management skills. Self-motivated, detail-oriented, and accountable.Our Commitment to Diversity & Inclusion Apexon is proud to be Certified™ by Great Place to Work® across the USA (five-time winner as of 2025), India (seven consecutive certifications as of 2024), and the UK. We are an equal opportunity employer and are committed to building an inclusive environment for all employees. We prohibit discrimination and harassment of any kind and ensure fair treatment regardless of gender, race, ethnicity, religion, disability, sexual orientation, gender identity or expression, or any other status protected by law. Learn more: Job Applicant Privacy PolicyPerks & Benefits Our rewards and benefits are crafted to promote personal and professional growth while caring for your well-being and that of your loved ones: Group Health Insurance for a family of four Term Life & Accident Insurance Paid Holidays & Earned Leaves Paid Parental Leave Learning & Career Development Programs Comprehensive Employee Wellness Initiatives
Job Title
Computer System Validation Engineer