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

About Betatest Solutions

Betatest Solutions Private Limited is a Bangalore-based IT consulting and software solutions firm dedicated to providing advanced technology solutions that help businesses achieve their full potential. Our team of highly skilled professionals utilizes their extensive expertise and technical knowledge to offer a wide range of IT services, including software development, network security, and IT infrastructure management. Recognizing the significant impact of technology on modern businesses and the industry's dynamic nature, we aim to deliver customized, cost-effective solutions tailored to each client's specific needs. We stay current with the latest technological advancements and market trends to ensure our clients receive optimal solutions.

About the Role

We are seeking a proficient Computer System Validation (CSV) Auditor with substantial experience in GAMP 5 Second Edition, FDA Computer Software Assurance (CSA), and risk-based validation strategies. The successful candidate will be tasked with evaluating computerized systems, performing validation and compliance audits, assessing vendor validation procedures, and ensuring adherence to global regulatory standards throughout the system lifecycle.

Key Responsibilities

• Determine the GxP impact, validation requirements, and criticality of computerized systems.
• Conduct risk-based assessments and reviews of validation applicability using methodologies such as GAMP 5, ICH Q9, FMEA, and criticality assessment.
• Execute independent audits of computerized systems, validation programs, and activities across the validation lifecycle.
• Review and analyze validation documentation, including URS, Functional Specifications, Design Specifications, Risk Assessments, IQ/OQ/PQ protocols, Validation Plans, Traceability Matrices, Validation Summary Reports, and Change Controls.
• Verify compliance with FDA 21 CFR Part 11, FDA CSA guidelines, GAMP 5 Second Edition, EU Annex 11, Annex 15, and Data Integrity requirements.
• Perform assessments of suppliers and vendor qualifications, evaluating software development practices and validation documentation.
• Conduct data integrity assessments to identify compliance gaps, risks, and areas for improvement.
• Evaluate various types of computerized systems, including cloud, SaaS, configurable, customized, infrastructure, laboratory, and enterprise systems.
• Assist with internal and external audits, regulatory inspections, and preparation for inspections.
• Provide recommendations for Corrective and Preventive Actions (CAPA) and improvements to validation governance based on audit findings.

Required Skills

• A solid grasp of Computerized System Validation (CSV) and Computer Software Assurance (CSA) principles.
• Practical experience applying GAMP 5 risk-based validation methodologies.
• Proven experience in conducting validation audits, compliance assessments, and supplier audits.
• Comprehensive understanding of computerized system lifecycle management.
• Experience with risk assessment tools and methodologies like FMEA, ICH Q9, and criticality assessments.
• Proficiency in reviewing documentation and evaluating compliance.
• In-depth knowledge of:
  • 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

• A strong foundation in risk-based validation and critical thinking.
• Exceptional skills in auditing, document review, and compliance assessment.
• Robust analytical and problem-solving abilities.
• Effective communication and stakeholder management capabilities.
• Meticulous attention to detail and an inspection-readiness mindset.
• Ability to work autonomously in highly regulated and audit-intensive environments.
• Thorough knowledge of computerized system lifecycle management and validation governance.

Additional Information

This role requires a candidate with a strong understanding of regulatory requirements within the pharmaceutical or related industries.