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.
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).

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Business Analyst Validation Expert Thiruvananthapuram
🏢 Quantiphi Analytics Solutions
📍 Thiruvananthapuram