About the role

Lead and execute IQ, OQ, and PQ for cloud platforms and virtualized environments using a GAMP 5 risk-based approach. Ensure systems meet FDA and EMA regulatory expectations, focusing on data integrity and Computer Software Assurance principles.

What they look for

GxP CSV Infrastructure Qualification Cloud Qualification AWS Azure GCP Virtualization Networking Validation GAMP 5 CSA Principles 21 CFR Part 11 EU Annex 11 ALCOA+ IAM RBAC Validation Documentation

Requirements

Requires 4+ years of experience in GxP CSV/Validation with at least 3 years of hands-on infrastructure and cloud qualification. Experience in regulated industries like Life Sciences or Healthcare and proficiency in security compliance tools is essential.

Full 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!