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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.
विवरण
- 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.
आवश्यकताएँ
- 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.
लाभ
- A culture centered on transparency, diversity, integrity, learning, and growth.
- An environment that encourages innovation and professional and personal development.
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