Computer System Validation( CSV)

Job Summary

We are seeking an experienced CSV/CSA Consultant to support validation and compliance activities for GxP-regulated systems within a Life Sciences environment. 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.
• Collaborate with Product Owners, Business Analysts, QA teams, and Technology teams.

Cloud & Infrastructure Validation

• Support qualification and validation of:
• SaaS Platforms
• Cloud Applications
• Infrastructure Components
• Virtualized Environments
• Databases
• Storage Systems
• Load Balancers
• Network Components
• Assess IaaS, PaaS, SaaS, and Hybrid Cloud architectures.

Data Integrity & AI/ML Compliance

• Evaluate data integrity controls including:
• Audit Trails
• User Access Management
• Electronic Records & Signatures
• ALCOA+ Principles
• Data Lineage
• Interfaces & Integrations
• Support validation of AI/ML-enabled systems considering model explainability, data quality, drift monitoring, human oversight, and periodic reviews.

Pharmacovigilance Support

• Support validation activities for Pharmacovigilance systems and safety platforms.
• Understand safety workflows, regulatory reporting requirements, and validation documentation associated with PV applications.

Learning Management Systems

• Support validation and operational activities for:
• LMS Platforms
• eLearning Applications
• Content Management Systems
• Develop training documentation and support training content authoring.

Required Qualifications

Education

• Bachelor's Degree in Computer Science, Information Technology, Life Sciences, Engineering, Pharmacy, or related field.

Experience

• 6+ years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), or Quality Compliance roles.
• Strong experience in GxP-regulated Life Sciences environments.
• Experience supporting Pharmacovigilance, Clinical, Quality, Manufacturing, or Regulatory systems.

Technical Skills

• GAMP 5
• Computer Software Assurance (CSA)
• Computer System Validation (CSV)
• FDA 21 CFR Part 11
• EU Annex 11
• Data Integrity & ALCOA+
• Risk Assessment
• Validation Lifecycle Management
• Agile SDLC & Waterfall SDLC
• Change Control & CAPA
• Audit & Inspection Readiness
• Cloud Validation
• Infrastructure Qualification (IQ)
• Operational Qualification (OQ)

Preferred Qualifications

• Experience with:
• ValGenesis
• Jira
• qTest
• ServiceNow
• Veeva
• TrackWise
• ComplianceWire
• LMS Platforms
• Knowledge of Pharmacovigilance systems such as:
• Argus
• ArisG
• SafetyEasy
• PV Works
• Experience validating AI/ML-enabled platforms.