Computer System Validation (CSV) / Computer Software Assurance (CSA) Specialist

Location: Hyderabad, Bengaluru, Chennai, Pune

Experience: 5+ Years

Employment Type: Contract 2 hire

Job Summary

We are seeking an experienced Computer System Validation (CSV) / Computer Software Assurance (CSA) Specialist to support validation, compliance, and quality assurance activities for GxP-regulated systems within a Life Sciences environment. The ideal candidate will possess strong expertise in risk-based validation methodologies, GAMP 5, CSA principles, data integrity, and regulated software delivery practices across cloud, SaaS, and enterprise applications.

The role will partner closely with Quality, Compliance, IT, Business, and Vendor teams to ensure systems remain validated, inspection-ready, and compliant with regulatory requirements while supporting modern agile delivery models.

Key Responsibilities

- Own validation strategy, risk assessments, validation scope, and testing approaches using GAMP 5 and Computer Software Assurance (CSA) principles, focusing on patient safety, product quality, and data integrity.
- Lead end-to-end validation lifecycle activities for GxP-regulated systems, including requirements management, specifications, traceability, testing, deviations, change control, CAPA support, and audit readiness.
- Apply GxP regulations, GAMP 5 methodology, and CSA principles across traditional, agile, SaaS, cloud-hosted, and contemporary digital platforms.
- Evaluate supplier documentation and vendor testing evidence to determine appropriate leverage based on risk, intended use, vendor assessment, release impact, and quality agreements.
- Support Infrastructure Qualification (IQ), Operational Qualification (OQ), Computer System Validation (CSV), Computer Software Assurance (CSA), risk assessments, IT quality, compliance, and governance initiatives.
- Participate in both Agile and Waterfall Software Development Lifecycle (SDLC) activities.
- Assess and validate data integrity controls, including audit trails, user access management, ALCOA+ principles, data lineage, interfaces, manual processes, and integrated systems.
- Support validation of AI/ML-enabled systems by evaluating intended use,



data quality, explainability, human oversight, model monitoring, drift detection, and revalidation requirements.
- Apply knowledge of Pharmacovigilance (PV) processes, workflows, regulatory requirements, and associated documentation to validation activities.
- Coordinate validation deliverables across multiple systems and applications while managing schedules, dependencies, stakeholder communications, and project milestones.
- Support IQ/OQ execution, user story reviews, test planning, training development, and validation documentation authoring.
- Provide operational and project support for eLearning and Learning Management System (LMS) platforms, including implementation, integration, maintenance, and sustainability initiatives.
- Monitor assigned actions, manage timelines, identify risks, and escalate issues appropriately to ensure successful delivery.

Required Qualifications
- Bachelor's degree in Computer Science, Information Technology, Life Sciences, Engineering, or a related discipline.
- Proven experience working with GxP-regulated systems and Computer System Validation (CSV).
- Strong understanding of GAMP 5, Computer Software Assurance (CSA), Data Integrity principles, and risk-based validation methodologies.
- Experience creating and maintaining validation documentation, traceability matrices, test scripts, deviation records, change controls, and audit-ready deliverables.
- Experience validating SaaS platforms, cloud-hosted applications, and qualified cloud infrastructure.
- Strong experience implementing Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within Agile delivery environments.
- Experience applying risk-based validation approaches to Agile releases, user stories, features, and product increments.
- Experience integrating quality, compliance,



and validation practices into Agile, Waterfall, and Hybrid SDLC frameworks.
- Strong background in IT Quality, IT Compliance, IT Risk Management, and Quality Oversight.
- Excellent stakeholder management, communication, documentation, and project coordination skills.
- Practical knowledge of infrastructure and network technologies, including servers, virtual machines, databases, storage systems, load balancers, and enterprise applications.
- Understanding of cloud computing models, including IaaS, PaaS, SaaS, Hybrid Cloud, and Managed Services.
- Strong analytical and problem-solving skills with attention to detail.

Preferred Qualifications
- Hands-on experience with JIRA, qTest, ServiceNow, and ValGenesis.
- Experience working with Pharmacovigilance systems and regulated Life Sciences environments.
- Experience supporting eLearning platforms and Learning Management Systems (LMS).
- Experience developing training materials, validation training programs, and eLearning content.
- Exposure to AI/ML system validation, governance, and compliance frameworks.
- Knowledge of FDA 21 CFR Part 11, EU Annex 11, GxP regulations, and data integrity guidance.
- Experience working with global teams and regulated enterprise environments.

Key Skills
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- GAMP 5
- GxP Compliance
- Data Integrity (ALCOA+)
- Risk-Based Validation
- Validation Lifecycle Management
- Audit Readiness
- CAPA & Change Control
- Agile & Waterfall SDLC
- Pharmacovigilance Systems
- Cloud Validation
- Infrastructure Qualification (IQ/OQ)
- IT Quality & Compliance
- AI/ML Validation
- JIRA, qTest, ServiceNow, ValGenesis

Why Join Us?
- Work on highly regulated and business-critical systems within the Life Sciences domain.
- Gain exposure to modern validation practices including CSA, cloud technologies, and AI-enabled platforms.
- Collaborate with cross-functional global teams across Quality, Compliance, IT, and Business functions.
- Contribute to initiatives that directly support patient safety, product quality, regulatory compliance, and operational excellence.

📌 Computer System Validation (CSV) Specialist (Hyderabad)
🏢 Dreampath Services
📍 Hyderabad