Senior Business Analyst - Validation Expert

Job description

While technology is the heart of our business, a global and diverse culture is the heart of our success. We love our people and we take pride in catering them to a culture built on transparency, diversity, integrity, learning and growth. If working in an environment that encourages you to innovate and excel, not just in professional but personal life, interests you- you would enjoy your career with Quantiphi! Role: Senior Business Analyst - Validation Expert Experience Level: 4 to 8 Years Work location: Mumbai/ Bengaluru/ Trivandrum Role & Responsibilities: • Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for cloud platforms (AWS, Azure, GCP), virtualized environments, network components, and storage/backup systems. • Develop and review validation deliverables like, Validation Plan, URS, FS/DS/CS, and Functional Level Risk Assessments, traceability matrix and Validation summary report, leveraging a GAMP 5 risk-based approach. • Perform hands-on protocol execution, including meticulous evidence capture (logs, screenshots, system outputs). • Define validation strategies for GxP-compliant cloud environments (IaaS, PaaS, SaaS) and qualify cloud services like IAM, logging, encryption, and backup/DR. • Ensure alignment with Computer Software Assurance (CSA) principles, focusing on critical thinking over documentation-heavy validation. • Ensure systems meet regulatory expectations from FDA and EMA, specifically 21 CFR Part 11 and EU Annex 11. • Interpret and apply data integrity principles (ALCOA+), audit trail requirements, and electronic records/e-signature controls. • Apply risk-based validation approaches per GAMP 5, including system categorization and GxP impact assessment, and drive CSA adoption to reduce over-documentation. • Support the validation lifecycle through periodic reviews, requalification, and change control impact assessments • Partner with IT and DevOps teams to validate infrastructure changes, patch management, and configuration drift. Primary Skill/Requirements: • 4+ years in GxP CSV/Validation, with 3+ years specifically in hands-on Infrastructure Qualification. • Proven hands-on experience in Cloud Qualification (AWS/Azure/GCP), Virtualization (VMware/Hyper-V), and Networking validation. • Experience in regulated industries such as Life science, Health care, or Medical Devices. • Proficiency in Security & Compliance aspects like IAM, RBAC, Encryption mechanisms, and SIEM/logging tools. • Familiarity with Validation tools (e.g., HP ALM, Azure DevOps, Jira) and creating essential Documentation (SOPs, Validation Plans, RTM). If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us*!*