Skills
GxP validation
IQ OQ PQ
risk-based validation
About the Role
Join our Regulatory, Risk, and Forensic team as a Senior Consultant and help clients drive system testing, validation, and compliance for complex GxP environments. You’ll support validation strategy, audit readiness, CAPA management, and risk-based compliance activities—especially as teams adopt AI/ML-enabled systems and automation frameworks.
Responsibilities
- Lead end-to-end validation for GxP systems, including validation plans, IQ/OQ/PQ protocols, summary reports, and required supporting documentation
- Develop and maintain user requirements, functional specifications, design specifications, and traceability matrices
- Apply risk-based validation approaches to evaluate system impact and determine appropriate validation scope
- Support audit readiness by ensuring documentation is complete, accurate, and defensible
- Assist with CAPA activities and help drive corrective and preventive actions to closure
- Identify emerging validation considerations for AI/ML-enabled systems and automation frameworks and translate them into practical guidance
Requirements
- Experience leading validation activities for GxP-regulated systems
- Strong working knowledge of IQ/OQ/PQ documentation and traceability practices
- Demonstrated understanding of risk-based validation and validation lifecycle governance
- Experience supporting audits and compliance reviews
- Ability to manage CAPA processes and support effective remediation
Benefits
- Opportunity to work on high-impact regulatory and compliance engagements
- Collaborative team environment focused on quality, risk management, and audit readiness
- Exposure to modern validation topics including AI/ML-enabled systems and automation frameworks
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