Suchita Dalal

Validation and Test Management professional with nearly 18 years of experience across Life Sciences, Pharmaceutical and Healthcare IT environments. Managed the full Labware LIMS validation lifecycle, overseeing defect triage, maintaining the traceability matrix, and delivering audit-ready Validation Summary Reports. Experienced in Computer System Validation (CSV), Computer Software Assurance (CSA), eDMS, Quality Document Management, CAPA, Deviations, Investigations(RCA), Quality Risk Assessment, GxP compliance, FDA 21 CFR Part 11, GAMP 4, HIPPA, RBAC, Veeva Vault, HP ALM and ServiceNow.

Proven track record of leading validation programs, managing global stakeholders up to VP level, driving audit readiness, and leading teams of up to 20 members. Skilled at identifying, prioritizing, & mitigating project risks & defects, facilitating proactive issue resolution, & ensuring high-quality product releases.

Associate Consultant – Test Manager at Tata Consultancy Services (2023-01 – 2025-09) Worked with a leading global pharmaceutical organization supporting regulated GxP applications.

• Led end-to-end Computer System Validation (CSV) activities across multiple projects in a regulated Life Sciences environment.
• Managed validation deliverables including Validation Plans, Test Protocols, RTMs, Defect Reports and Validation Summary Reports (VSRs).
• Oversaw a team of 16–20 validation and QA professionals across multiple concurrent projects.
• Supported 4 validation programs, successfully delivering 2 while managing validation activities for 2 parallel initiatives.
• Maintained audit-ready validation documentation and supported internal compliance audits across regulated environments.
• Ensured compliance with FDA 21 CFR Part 11, GxP requirements and GAMP 5 guidelines.
• Worked extensively on Veeva Vault Quality Suite including QMS, QualityDocs, Training and Validation Management modules.
• Applied risk-based CSA principles to optimize validation effort and improve delivery efficiency. QA Team Lead / Senior Software Test Engineer / Test Engineer at Cross Country InfoTech Pvt. Ltd. (2007-09 – 2022-12) Delivered QA support across enterprise Healthcare IT platforms for a large US-based healthcare organization.
• Led QA delivery teams of 10–12 members across multiple Healthcare IT applications.
• Managed functional, integration, regression, UAT and API testing activities with risk-based coverage prioritized for patient data modules.
• Managed CSV documentation lifecycle in Veeva Vault QualityDocs from Validation Test Plan through Validation Summary Report sign-off by keeping all evidence audit-ready.
• Applied HIPAA compliance throughout testing which includes PHI masking in test environments, RBAC validation across clinical and billing roles, and audit trail verification on every patient record access.
• Implemented process improvements and quality practices that improved release stability and reduced recurring defects.
• Conducted API validation using Postman and cloud integration testing involving AWS services.
• Performed security testing activities using Burp Suite and coordinated remediation tracking.
• Collaborated with business stakeholders, project managers, architects and development teams to ensure successful project delivery.
• Mentored junior team members on testing practices and the reasoning behind HIPAA and CSV requirements.
• Facilitated sprint planning, backlog grooming, defect triage and stakeholder reviews as Scrum Master.

Bachelor of Science – Nagpur University

Diploma in Software Testing – SEED InfoTech Pvt. Ltd., Pune

Diploma in Software Technology – CIC-CCIT, Nagpur