Computer System Validation (CSV) Auditor (GAMP 5 Focused)

Betatest Solutions; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Betatest Solutions in Bengaluru is seeking a skilled Computer System Validation Auditor to assess computerized systems and ensure compliance with regulatory requirements. The role involves conducting independent audits, evaluating supplier practices, and identifying compliance gaps.

The ideal candidate will have expertise in GAMP 5 and FDA Computer Software Assurance principles, along with strong analytical skills and the ability to work in highly regulated environments.

Qualifications

• Expertise in GxP impact assessment and validation applicability.
• Hands-on experience with compliance audits and inspections.
• Strong attention to detail and risk evaluation skills.

Responsibilities

• Assess computerized systems for GxP impact and validation.
• Conduct audits of computerized systems and vendor qualifications.
• Review validation deliverables and ensure compliance with regulations.

Skills

Computerized System Validation (CSV)

Computer Software Assurance (CSA)

GAMP 5

Risk-based validation methodologies

FDA 21 CFR Part 11 compliance

Supply audits

Data integrity assessments

Criticality assessment methodologies

Job description

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.