Associate Engagement Manager (GxP Validation Expert)
Quantiphi
IN MH Mumbai Eureka; IN KA Bengaluru Posted 7 days agoDiscoveredMatch locked
Full time3+ years exp
About the role
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:
Role & Responsibilities
The ideal candidate will lead and execute GxP validation activities across various infrastructure components. This includes:
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Infrastructure Qualification
Leading IQ, OQ, and PQ for cloud platforms (AWS, Azure, GCP), virtualized environments, network components, and storage/backup systems.
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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.
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Hands-on Execution
Performing protocol execution with meticulous evidence capture (logs, screenshots, system outputs).
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Cloud Validation Strategy
Defining validation strategies for GxP-compliant cloud environments (IaaS, PaaS, SaaS) and qualifying cloud services (IAM, logging, encryption, backup/DR).
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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.
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CSA & GAMP 5
Applying risk-based validation per GAMP 5, including system categorization and GxP impact assessment, and driving Computer Software Assurance (CSA) adoption.
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Lifecycle Support
Supporting the validation lifecycle through periodic reviews, requalification, and change control impact assessments.
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Collaboration
Partnering with IT and DevOps teams for infrastructure changes, patch management, and configuration drift validation.
Primary Requirements
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Experience
5+ years in GxP CSV/Validation, with 3+ years specifically in hands-on Infrastructure Qualification.
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Technical Expertise
Proven hands-on experience in Cloud Qualification (AWS/Azure/GCP), Virtualization (VMware/Hyper-V), and Networking validation.
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Industry Background
Experience in regulated industries (Life Science, Healthcare, Medical Devices).
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Security & Compliance
Proficiency in IAM, RBAC, Encryption mechanisms, and SIEM/logging tools.
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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 !
Not included in the source posting: about the role, benefits.
Skills
azuredevopsawsgcpiamartificial-intelligencejiramachine-learningsiemterraformexcel
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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