Febin K Ponnachen

Software Development Lead with 5+ years of experience delivering enterprise eQMS solutions across healthcare and life sciences domains. Proven expertise in IQVIA SmartSolve (SaaS eQMS) with hands-on leadership in CAPA, Deviation, Complaint, Change, and Supplier Management modules. Strong background as a Business Analyst and Technical Lead, driving client demos, requirement gathering, gap analysis, and solution design for 30+ enterprise clients.

Recognized for fast response, SmartSolve domain expertise, and zero-defect production releases.

Software Development Engineer 2 / Business Analyst (eQMS) - IQVIA (India) Private Limited - Kochi, Kerala, India

(2022-10)

• Led end-to-end configuration, customization, and delivery of SmartSolve eQMS solutions for 30+ global life sciences clients.
• Designed and configured workflows for CAPA, Deviation, Complaint, Change Management, and Supplier Management, aligning system behaviour with client-specific quality processes and regulatory requirements.
• Implemented XML-based workflow automation, approval hierarchies, escalations, and notifications—improving operational efficiency by ~40%.
• Ensured zero critical post-production defects across multiple regulated production releases by owning development, validation, and UAT readiness.
• Acted as Business Analyst and Solution Lead for 5+ enterprise clients, driving requirement gathering, gap analysis, and solution design for eQMS implementations and enhancements.
• Conducted client demos, design walkthroughs, and stakeholder workshops, translating complex quality requirements into scalable SmartSolve configurations.
• Received direct client appreciation for fast response times, deep SmartSolve domain knowledge, and solution clarity.
• Created functional documentation and configuration specifications to ensure alignment across business, QA, and engineering teams.
• Performed SQL-based backend validation across eQMS modules, improving audit readiness and reducing data inconsistencies by 45%.
• Developed and delivered 50+ Crystal Reports covering CAPA effectiveness, deviation trends, complaint metrics, supplier performance, and audit reporting—reducing manual effort by 60%.
• Supported API-based integrations and cross-system data validation, ensuring seamless enterprise connectivity.
• Led UAT planning and execution, achieving 100% acceptance rates prior to go-live.
• Managed defect lifecycle via Jira, reducing resolution turnaround time by 30% through structured RCA and prioritization.
• Mentored junior team members on eQMS workflows, validation principles, and best practices, strengthening overall delivery quality.
• Awarded IQVIA Ovation Award and Bronze Award for leadership, ownership, and delivery excellence.

QA Analyst - Manpower Group Services India Pvt Ltd

(2021-03 - 2022-10)

• Worked as QA Analyst on Salesforce OCE Personal and OCE Digital platforms, validating application functionality across sales, engagement, and data workflows.
• Designed and executed functional, regression, and integration test cases, ensuring high-quality releases and system stability.
• Built automated test scripts using Excel-driven automation framework, automating high-volume regression test scenarios.
• Reduced manual testing effort by ~50% through structured test automation, significantly improving release turnaround time.
• Performed data validation and backend verification, ensuring accuracy across Salesforce OCE modules.
• Collaborated with developers and business stakeholders to identify defects, perform root cause analysis, and ensure timely resolution.
• Preapared Test Plan, Test cases and Traceability matrices
• Used Tools like Jira and Test rail to log defects and track bugs.

Bachelor of Technology (B.Tech) - Biotechnology - APJ Abdul Kalam technological University (2020)