GMP Compliance & Validation Subject Matter Expert – AI Model Evaluation

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $25 - $50 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🤖 Artificial Intelligence

Where this job comes from

Posted on Volga Partners's careers page, not through a job board

First seen by Remote Rocketship 6 minutes ago

Logo of Volga Partners

Volga Partners

1001 - 5000 employees

Founded 2020

🤖 Artificial Intelligence

🤝 B2B

🏢 Enterprise

Artificial Intelligence • B2B • Enterprise

Volga Partners is a technology services firm that specializes in Artificial Intelligence and Machine Learning solutions, data annotation and labeling, and development of customer service platforms powered by generative AI. The company also provides IT and software development services across web, app, full-stack, cybersecurity advisory, and e-commerce support, supported by a large multilingual crowd workforce and remote on-demand resources. Volga Partners focuses on partnering with enterprise clients to deliver scalable, cost-effective AI tooling, content moderation, linguistic services, and managed software projects.

📋 Description

• Evaluate AI-generated pharmaceutical content for scientific, technical, and regulatory accuracy, completeness, consistency, and compliance • Review content related to quality systems, manufacturing, validation, submissions, development, and compliance activities • Analyze whether AI-generated conclusions are supported by scientific principles, regulatory expectations, and industry best practices • Identify unsupported claims, technical inaccuracies, missing context, inconsistencies, and flawed reasoning • Reference FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices to validate information • Provide expert feedback, explain findings, identify improvements, and recommend technically accurate corrections • Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI quality improvement • Complete independent evaluations using designated online platforms accurately and within project timelines

🎯 Requirements

• Minimum of 4 years of professional experience in GMP Compliance, Validation, Quality Engineering, Manufacturing Compliance, Computer System Validation, or related pharmaceutical functions • Bachelor's degree or higher in Pharmaceutical Sciences, Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Biomedical Engineering, Life Sciences, Engineering, or a related discipline • Experience supporting validation and qualification activities within regulated pharmaceutical or biotechnology environments • Experience with process validation, cleaning validation, equipment qualification, facility qualification, or computerized system validation • Strong knowledge of FDA regulations, GMP requirements, and relevant ICH guidelines • Familiarity with data integrity principles, 21 CFR Part 11 requirements, and risk-based validation approaches • Experience reviewing validation documentation, protocols, reports, and compliance records • Strong analytical, research, and problem-solving skills • Excellent written English communication skills • Ability to work independently and follow detailed review instructions • Comfortable working 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 contributing to AI evaluation initiatives • No AI background required • Work from an eligible location

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