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 settings (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.
Prof

📌 Senior Business Analyst Mumbai
🏢 Quantiphi Analytics Solutions
📍 Mumbai