The Validation SME provides leadership and expertise for computerized system validation (CSV), Agile Development Lifecycle (ADLC), Software Development Lifecycle (SDLC), and AI/ML validation activities. The role ensures that digital solutions, AI/ML models, and regulated computerized systems comply with internal procedures, quality standards, regulatory requirements, and industry best practices throughout their lifecycle.

Key Responsibilities -

Validation Strategy & Planning:

Develop and maintain validation plans, testing strategies, and verification approaches.

Define validation scope, risk-based testing strategies, and compliance requirements.

Participate in solution assessments, CRS reviews, ERES assessments, and impact assessments.

Support deployment and validation activities for new implementations and enhancements.

Requirements & Risk Management:

Review business and functional requirements for testability and compliance.

Support requirements risk assessments and traceability activities.

Ensure regulatory and business requirements are adequately addressed within validation deliverables.

Test Design & Execution:

Create and review verification protocols and test scripts.

Coordinate system, integration, functional, data migration, and non-functional testing.

Review test evidence, defects, deviations, and corrective actions.

Ensure testing is performed according to approved procedures and standards.

Compliance & Quality Oversight:





Ensure compliance with:

FDA 21 CFR Part 11

GAMP 5

GMP/GxP requirements

Internal SOPs and Quality Standards

Support inspections, audits, and quality reviews.

Ensure systems remain in a validated state throughout their lifecycle.

AI/ML Validation (where applicable):

Prepare and approve AI/ML model validation documentation.

Collaborate with model owners, data scientists, and business SMEs.

Support AI risk assessments, model verification, bias testing, explainability testing, performance monitoring, and AI lifecycle governance.

Review AI monitoring plans and model evaluation reports.

Cross-Functional Collaboration

Work closely with Business SMEs, Product Owners, Technical SMEs, Quality SMEs, Data Scientists, and Site Teams.

Participate in change control reviews and deployment readiness assessments.

Provide validation guidance and mentoring to project teams.

Required Qualifications:

Bachelor's or Master's degree in Life Sciences, Engineering, Computer Science, Information Systems, Quality, or related field.

5+ years of experience in Computerized System Validation (CSV), Quality Assurance, or regulated system implementation.

Solid knowledge of:

GxP regulations

FDA requirements

GAMP 5

Risk-based validation methodologies

SDLC/ADLC processes

Experience with validation documentation, testing, traceability, and audit support.

📌 Pharma Validation AI ML SME (India)
🏢 CygnusPro Software Solutions Private
📍 India