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If working in an workplace that encourages you to innovate and excel, not just in professional but personal life, interests you- you would enjoy your career with Quantiphi
Role: Associate Engagement Manager - GxP Validation Expert
Experience Level: 5-12 Years
Work location: Mumbai, Bengaluru, Trivandrum

Role & Responsibilities:
The ideal candidate will lead and execute GxP validation activities across various infrastructure components. This includes:
• Infrastructure Qualification: Leading IQ, OQ, and PQ for cloud platforms (AWS, Azure, GCP), virtualized environments, network components, and storage/backup systems.
• Validation Deliverables: Developing and reviewing key validation documents (Validation Plan, URS, FS/DS/CS, Risk Assessments, Traceability Matrix, Validation Summary Report) using a GAMP 5 risk-based approach.




• Hands-on Execution: Performing protocol execution with meticulous evidence capture (logs, screenshots, system outputs).
• Cloud Validation Strategy: Defining validation strategies for GxP-compliant cloud environments (IaaS, PaaS, SaaS) and qualifying cloud services (IAM, logging, encryption, backup/DR).
• Regulatory Compliance: Ensuring alignment with FDA (21 CFR Part 11) and EMA (EU Annex 11) regulations, applying ALCOA+ principles, audit trail requirements, and electronic records/e-signature controls.
• CSA & GAMP 5: Applying risk-based validation per GAMP 5, including system categorization and GxP impact assessment, and driving Computer Software Assurance (CSA) adoption.
• Lifecycle Support: Supporting the validation lifecycle through periodic reviews, requalification, and change control impact assessments.
• Collaboration: Partnering with IT and DevOps teams for infrastructure changes, patch management,

📌 Associate Engagement Manager (Bengaluru)
🏢 Quantiphi
📍 Bengaluru