About this role
Associate Engagement Manager (GxP Validation Expert)
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 (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!
Welcome
Thank you for your interest in Quantiphi!
We are a team that dreams together and collaborates to ensure success. We are currently looking for exceptional individuals who can join us and contribute to a fun, diverse and hybrid work culture. As a part of the Quantiphi family, you will get ample opportunities to learn, grow and interact with colleagues from varied experience and backgrounds around the globe.
If this excites you, explore our current openings and apply to any job roles that suit and interest you.
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About Us
Quantiphi is an award-winning AI-first digital engineering company driven by the desire to reimagine and realize transformational opportunities at the heart of business. We solve the toughest and most complex business problems with the latest and cutting-edge technologies and to make this happen, we have a vibrant, diverse and talented set of professionals we proudly refer to as the Quantiphi family.
Our culture is built on transparency, diversity, integrity, learning and growth. We are committed to provide our teams with an environment that helps them to learn and grow and flourish in their professional as well as personal lives.
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