Associate Engagement Manager GxP Validation Expert

Quantiphi; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Quantiphi is seeking an Associate Engagement Manager - GxP Validation Expert to lead infrastructure qualification and GxP validation across cloud platforms like AWS/Azure/GCP. The role requires 5+ years in GxP CSV/Validation, with 3+ years hands-on IQ experiences in regulated environments.

You will collaborate with IT/DevOps to validate cloud solutions, ensure compliance with FDA/EMA, and drive CSA adoption while delivering comprehensive validation artifacts.

Qualifications

• 5+ years in GxP CSV/Validation with 3+ years 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 (Life Science, Healthcare, Medical Devices).
• Proficiency in IAM, RBAC, Encryption mechanisms, and SIEM/logging tools.
• Familiarity with Validation tools (HP ALM, Azure DevOps, Jira) and creating SOPs, Validation Plans, RTM.

Responsibilities

• Lead Infrastructure Qualification: IQ/OQ/PQ for cloud platforms and virtualization environments.
• Develop and review validation deliverables using a risk-based approach (GAMP 5).
• Perform protocol execution with evidence capture (logs, screenshots, system outputs).
• Define validation strategies for GxP-compliant cloud environments and qualify cloud services.
• Ensure FDA 21 CFR Part 11 and EMA EU Annex 11 compliance, ALCOA+ principles, and e-signatures controls.
• Apply risk-based validation per GAMP 5 and drive CSA adoption.
• Support lifecycle validation through reviews, requalification, and change control impact assessments.
• Collaborate with IT/DevOps for infrastructure changes and drift validation.

Skills

GxP CSV Validation

Infrastructure Qualification

Cloud Qualification (AWS/Azure/GCP)

VMware/Hyper-V

Networking validation

Security & Compliance

Validation documentation

Tools

HP ALM

Azure DevOps

Jira

Job description

Job 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: 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.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us