GMP Compliance & Validation Subject Matter Expert – AI Model Evaluation

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess AI-generated pharmaceutical content for scientific, technical, and regulatory precision, completeness, consistency, and compliance.

• Examine content associated with quality systems, manufacturing, validation, submissions, development, and compliance activities.

• Evaluate whether AI-generated conclusions are grounded in scientific principles, regulatory requirements, and industry best practices.

• Detect unsupported claims, technical inaccuracies, missing context, inconsistencies, and flawed reasoning.

• Utilize FDA requirements, GMP regulations, ICH guidelines, and established pharmaceutical industry practices to verify information.

• Offer expert insights, clarify findings, pinpoint enhancements, and suggest technically accurate corrections.

• Implement project-specific evaluation criteria, scoring guidelines, and quality standards to facilitate AI quality enhancement.

• Conduct independent evaluations using designated online platforms accurately and within established project timelines.

⛳️ Requirements

• At least 4 years of professional experience in GMP Compliance, Validation, Quality Engineering, Manufacturing Compliance, Computer System Validation, or similar pharmaceutical roles.

• A Bachelor's degree or higher in Pharmaceutical Sciences, Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Biomedical Engineering, Life Sciences, Engineering, or a related field.

• Proven experience in supporting validation and qualification activities within regulated pharmaceutical or biotechnology settings.

• Background in process validation, cleaning validation, equipment qualification, facility qualification, or computerized system validation.

• In-depth knowledge of FDA regulations, GMP standards, and pertinent ICH guidelines.

• Understanding of data integrity principles, 21 CFR Part 11 requirements, and risk-based validation methodologies.

• Experience reviewing validation documentation, protocols, reports, and compliance records.

• Strong analytical, research, and problem-solving abilities.

• Exceptional written English communication skills.

• Capability to work autonomously and adhere to detailed review instructions.

• Comfortable operating within a task-based freelance engagement model.

🏝️ Benefits

• Remote work arrangement.

• Flexible, variable, assignment-based schedule.

• Project-based assignments suitable for supplemental income.

• Opportunity to contribute to advanced AI technologies.

• Experience participating in AI evaluation initiatives.

• No AI background necessary.

• Work from an eligible location.