Job highlights

- Secondary Requirements (Good to Have)
- Experience Level: 5-12 Years . Work Location is Mumbai,Bengaluru,Trivandrum
- Experience with specific GxP application systems (e.g.,LIMS,QMS,MES,Veeva Vault).
- Experience with Infrastructure as Code (IaC) tools (Terraform,CloudFormation).

Job Summary 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, 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 (Valuable 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.

📌 Associate Engagement Manager (GxP Validation Expert) (Mumbai)
🏢 Quantiphi
📍 Mumbai