Job Summary
We are seeking an experienced CSV/CSA Consultant to support validation and compliance activities for GxP-regulated systems within a Life Sciences setting. The candidate will be responsible for applying GAMP 5, Computer Software Assurance (CSA), and risk-based validation methodologies across traditional, cloud, SaaS, Agile, and AI/ML-enabled platforms. The role requires expertise in Computer System Validation, Data Integrity, IT Compliance, Pharmacovigilance systems, and Quality Risk Management.

Key Responsibilities

Validation & Compliance
Lead and execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.
Define validation strategy, testing approach, risk assessments, and validation deliverables following GAMP 5 and CSA principles.
Develop and review Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Traceability Matrix (TM), Test Scripts, Test Summary Reports (TSR), and Validation Reports.
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11,



GxP, and Data Integrity requirements.
Risk-Based Validation
Conduct System Risk Assessments (SRA) and Functional Risk Assessments (FRA).
Apply CSA methodologies to focus testing on critical system functions impacting patient safety, product quality, and data integrity.
Leverage supplier documentation and vendor testing evidence based on risk evaluations and supplier assessments.
Quality & IT Compliance
Support change control, deviations, CAPA investigations, audit readiness, regulatory inspections, and quality governance activities.
Participate in IT Quality Management and Quality Risk Management programs.
Ensure validation deliverables meet internal SOPs and global regulatory expectations.
Agile & Digital Platforms
Support Agile, Waterfall, and Hybrid SDLC methodologies.
Integrate validation activities with Sprint planning, user stories, release management, and product increments.
Co

📌 Computer System Validation( CSV) (Hyderabad)
🏢 cirruslabs
📍 Hyderabad