Senior Business Analyst - Validation Expert

Senior Business Analyst - Validation Expert

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).

Experience Level

Senior Level