Associate Engagement Manager (GxP Validation Expert)

Quantiphi Analytics Solutions; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Quantiphi Analytics Solutions seeks an Associate Engagement Manager - GxP Validation Expert to support GxP CSV/Validation across Mumbai, Bengaluru and Trivandrum. The role requires 5–12 years of experience with a focus on hands-on infrastructure qualification and cloud validation strategies.

You will lead IQ/OQ/PQ for cloud platforms, create and review validation documents, perform protocol execution with detailed evidence, and ensure compliance with FDA and EMA regulations while driving CSA

Qualifications

• 5+ years of experience in GxP CSV/Validation.
• 3+ years hands-on Infrastructure Qualification.
• Proven cloud qualification experience (AWS/Azure/GCP) and virtualization.
• Experience with IAM, RBAC, encryption, and SIEM/logging tools.
• Familiarity with validation tools (HP ALM, Azure DevOps, Jira) and documentation (SOPs, Validation Plans, RTM).

Responsibilities

• Lead IQ, OQ, and PQ for cloud platforms (AWS, Azure, GCP) and virtualized environments.
• Develop and review validation deliverables (Validation Plan, URS, FS/DS/CS, Risk Assessments, RTM, Validation Summary Report).
• Perform protocol execution with evidence capture (logs, screenshots, outputs).
• Define validation strategies for GxP-compliant cloud environments (IaaS, PaaS, SaaS).
• Ensure alignment with FDA 21 CFR Part 11 and EMA EU Annex 11 regulations.
• Apply GAMP 5 risk-based validation and promote CSA adoption.
• Support lifecycle through reviews, requalification, and change control.
• Collaborate with IT/DevOps on infrastructure changes and drift validation.

Skills

GxP Validation

Infrastructure Qualification

Cloud Qualification

IAM & RBAC

Encryption & SIEM

Validation Tools

Tools

HP ALM

Azure DevOps

Jira

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.