Key skills
Product Management
About this role
Role Overview
- Develop and execute validation protocols (IQ/OQ/PQ) for software systems and tools used in GxP environments
- Author and maintain validation documentation including validation master plans, protocols, reports, and standard operating procedures
- Follow comprehensive validation plans following GAMP 5 principles, including risk-based approaches to validation activities
- Ensure all validation activities comply with 21 CFR Part 11, GAMP 5, ISO 9001 and applicable FDA guidance
- Maintain validation documentation in accordance with quality management system requirements
- Support audit and inspection readiness through comprehensive validation records
- Partner with Software Engineering, Product Management and Quality Management on developing and reviewing validation artifacts
- Support Change Control activities and assess validation impact of system changes
Requirements
- Experience in software validation, computer system validation (CSV), or related quality/compliance role within a regulated life sciences environment (pharma, biotech, or medical device)
- Strong understanding of GAMP 5 principles and risk-based validation approaches
- Working knowledge of 21 CFR Part 11 requirements for electronic records and signatures
- Familiarity with ISO 9001 quality management system principles