Associate Engagement Manager (GxP Validation Expert)

Quantiphi Analytics Solutions; Bengaluru; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Quantiphi Analytics Solutions is seeking an Associate Engagement Manager - GxP Validation Expert. The role focuses on robust validation across cloud platforms and infrastructure, ensuring compliance with global regulations, and partnering with IT/DevOps for secure, auditable systems.

Experience in regulated industries and hands-on infrastructure qualification are essential to lead validation lifecycle activities and deliver quality documentation.

Qualifications

• 5+ years in GxP CSV/Validation.
• Hands-on experience with infrastructure qualification.

Responsibilities

• Infrastructure Qualification: Lead IQ, OQ, PQ for cloud platforms (AWS, Azure, GCP) and virtualization.
• Validation Deliverables: Develop/review Validation Plans, URS, FS/DS/CS, RTM.
• Hands-on Execution: Perform protocol execution with evidence capture.
• Cloud Validation Strategy: Define strategies for GxP cloud environments (IaaS, PaaS, SaaS).
• Regulatory Compliance: Ensure FDA 21 CFR Part 11 and EMA EU Annex 11 alignment.
• CSA GAMP 5: Apply risk-based validation and promote CSA adoption.
• Lifecycle Support: Support validation lifecycle with reviews and change control.
• Collaboration: Partner with IT and DevOps for changes and validation.

Skills

GxP CSV

Cloud Qualification

IAM & RBAC

SOP Documentation

Validation Tools

DevOps Knowledge

Tools

HP ALM

Azure DevOps

Jira

Terraform

CloudFormation

Job description

Job Summary

• Role: Associate Engagement Manager - GxP Validation Expert
• Experience Level: 5-12 Years
• Work location: Mumbai, Bengaluru, Trivandrum

Role Responsibilities

• 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, and configuration drift validation.

Primary Requirements

• Experience: 5+ years in GxP CSV/Validation, with 3+ years specifically in hands-on Infrastructure Qualification.
• Technical Expertise: Proven hands-on experience in Cloud Qualification (AWS/Azure/GCP), Virtualization (VMware/Hyper-V), and Networking validation.
• Industry Background: Experience in regulated industries (Life Science, Healthcare, Medical Devices).
• Security Compliance: Proficiency in IAM, RBAC, Encryption mechanisms, and SIEM/logging tools.
• Tools Documentation: Familiarity with Validation tools (e.g., HP ALM, Azure DevOps, Jira) and creating essential Documentation (SOPs, Validation Plans, RTM).

Secondary Requirements (Good to Have)

• Experience with specific GxP application systems (e.g., LIMS, QMS, MES, Veeva Vault).
• Experience with Infrastructure as Code (IaC) tools (Terraform, CloudFormation).
• Knowledge of DevOps / CI-CD validation practices.
• Knowledge of AI/ML system validation.
• Experience with automated testing tools.
• Ability to design validation strategies and troubleshoot qualification issues.

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.