Senior Tech Specialist, Cloud Engineering - R01573611
Brillio (company site, opens in a new tab)6+ yrsBengaluruOn-siteDirect career pageEst. 14–24 LPA
Posted 3h ago
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Job description
Structured overview of role & requirements
About This Role
- Lead governance and compliance of cloud IT platforms throughout system development lifecycle in pharmaceutical or life sciences context.
- Plan and execute Computer System Validation and Assurance activities using GAMP 5 risk-based methodology including IQ/OQ/PQ qualifications.
- Manage validation documentation, regulatory compliance, deviation and change controls, and support audits and regulatory inspections.
Minimum Requirements
- At least 6 years of experience in IT quality, system validation, and compliance for cloud platforms in pharmaceutical or life sciences industry.
- Strong knowledge and hands-on experience with GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, Computer System Validation (CSV/CSA), and cloud platform qualification (IQ/OQ/PQ).
- Proficiency with validation documentation, IT change and release management, and electronic signature platforms like DocuSign.
- Bachelor's degree in Computer Science, IT, Pharmaceutical Sciences, or related field.
Ideal Candidate Profile
- Experienced in regulated life sciences environments with a focus on cloud platform validation and compliance governance.
- Skilled in managing cross-functional coordination with QA, IT, business owners, and regulatory teams for audit readiness and compliance.
- Familiar with AI/GenAI governance, GDPR, data privacy, and preferred cloud platforms (e.g., Snowflake, Azure, AWS) in regulated settings.