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Quantiphi is an AI-first digital engineering company that helps organizations apply artificial intelligence, data, and cloud technologies to complex business challenges. Founded in 2013, the company combines consulting and engineering expertise to build scalable AI applications, develop data analytics capabilities, modernize cloud infrastructure, and deliver custom implementations. Its work supports organizations in sectors such as healthcare, finance, education, retail, and logistics, with technology partnerships including AWS, Google Cloud, and NVIDIA. Quantiphi’s teams focus on turning advanced technology into practical solutions for enterprise transformation.
Associate Engagement Manager, GxP Validation — Mumbai On-site
Lead GxP validation and cloud infrastructure qualification for Quantiphi. Support regulated life sciences systems from an on-site role in Mumbai, Bengaluru, or Trivandrum.
Description
- Lead GxP validation across infrastructure components.
- Direct IQ, OQ, and PQ for cloud platforms, virtualized environments, networks, and storage and backup systems.
- Create and review validation plans, URS, FS/DS/CS, risk assessments, traceability matrices, and summary reports using GAMP 5 risk-based methods.
- Execute protocols and capture evidence such as logs, screenshots, and system outputs.
- Set validation strategies for GxP-compliant IaaS, PaaS, and SaaS environments.
- Qualify cloud services, including IAM, logging, encryption, and backup and disaster recovery.
- Maintain alignment with FDA 21 CFR Part 11 and EMA EU Annex 11.
- Apply ALCOA+ principles, audit trail requirements, and controls for electronic records and signatures.
- Use GAMP 5 risk-based validation, including system categorization and GxP impact assessments.
- Promote adoption of Computer Software Assurance.
- Support the validation lifecycle through periodic reviews, requalification, and change-control impact assessments.
- Work with IT and DevOps teams on infrastructure changes, patch management, and configuration drift validation.
Requirements
- The stated experience range is 5–12 years.
- At least 5 years of GxP CSV or validation experience.
- At least 3 years of hands-on infrastructure qualification experience.
- Hands-on cloud qualification experience with AWS, Azure, or GCP.
- Experience with VMware or Hyper-V virtualization.
- Experience validating network components.
- Experience in a regulated field such as life sciences, healthcare, or medical devices.
- Proficiency in IAM, RBAC, encryption, and SIEM or logging tools.
- Familiarity with validation tools such as HP ALM, Azure DevOps, and Jira.
- Experience creating SOPs, validation plans, and RTMs.
- Preferred: experience with LIMS, QMS, MES, or Veeva Vault.
- Preferred: experience with Terraform or CloudFormation.
- Preferred: knowledge of DevOps or CI/CD validation practices.
- Preferred: knowledge of AI/ML system validation.
- Preferred: experience with automated testing tools.
- Ability to design validation strategies and troubleshoot qualification issues.
Benefits
- A culture centered on transparency, diversity, integrity, learning, and growth.
- An environment that encourages innovation and professional and personal development.
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