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 setting 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 infrastructu

📌 Senior Business Analyst (Bengaluru)
🏢 Quantiphi
📍 Bengaluru