Computer System Validation Auditor (GAMP 5 Focused)

Location: Remote

Experience: 4-8 years

Shift timing: 7:30 PM to 4:30 AM IST

About the role:

We are looking for a skilled Computer System Validation (CSV) Auditor with strong expertise in GAMP 5 Second Edition, FDA Computer Software Assurance (CSA), and risk-based validation methodologies. The candidate will be responsible for assessing computerized systems, conducting validation and compliance audits, evaluating supplier validation practices, and ensuring systems comply with global regulatory requirements throughout their lifecycle.

Key Responsibilities:

• Assess computerized systems to determine GxP impact, validation applicability, and system criticality.

• Perform risk-based assessments and validation applicability reviews using GAMP 5, ICH Q9, FMEA, and

criticality assessment methodologies.

• Conduct independent audits of computerized systems, validation programs, and validation lifecycle

activities.

• Review and evaluate validation deliverables including URS, Functional Specifications, Design

Specifications, Risk Assessments, IQ/OQ/PQ protocols, Validation Plans, Traceability Matrices,

Validation Summary Reports, and Change Controls.

• Assess compliance with FDA 21 CFR Part 11, FDA CSA guidance, GAMP 5 Second Edition, EU Annex 11,

Annex 15, and Data Integrity requirements.

• Perform supplier assessments and vendor qualification reviews to evaluate software development

practices and validation documentation.

• Conduct data integrity assessments and identify compliance gaps, risks, and remediation opportunities.

• Evaluate cloud, SaaS, configurable, customized, infrastructure, laboratory, and enterprise computerized

systems.

• Support internal audits, external audits, regulatory inspections, and inspection readiness activities.

• Provide CAPA recommendations and validation governance improvements based on audit findings.

Required Skills:

• Strong understanding of Computerized System Validation (CSV) and Computer Software Assurance

(CSA) principles.

• Hands-on experience with GAMP 5 risk-based validation methodologies.

• Experience conducting validation audits, compliance assessments, and supplier audits.

• Strong knowledge of computerized system lifecycle management.

• Experience performing risk assessments using FMEA, ICH Q9, and criticality assessments.

• Strong documentation review and compliance evaluation skills.

• In-depth knowledge in the following:

GAMP 5 Second Edition

FDA Computer Software Assurance (CSA)

FDA 21 CFR Part 11

EU GMP Annex 11 & Annex 15

ICH Q9 and ICH Q10

ALCOA+ Data Integrity Principles

CSV and SDLC methodologies

Key Competencies:

• Strong understanding of risk-based validation and critical thinking approaches.

• Excellent auditing, documentation review, and compliance assessment skills.

• Strong analytical and problem-solving capabilities.

• Effective communication and stakeholder management skills.

• High attention to detail and inspection-readiness mindset.

• Ability to work independently within highly regulated and audit-driven environments.

• Strong knowledge of computerized system lifecycle management and validation governance.