GMP Compliance & Validation Subject Matter Expert – AI Model Evaluation
V
Volga PartnersPharmaceutical AI
Remote | United States | Project-Based Independent ContractorContractMiddle
Salary25 - 50 USD per hour
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Job Details
- Languages
- Excellent written English communication skills
- Experience
- Minimum of 4 years of professional experience in GMP Compliance, Validation, Quality Engineering, Manufacturing Compliance, Computer System Validation, or related pharmaceutical functions
Requirements
- Have a minimum of 4 years of professional experience in GMP Compliance, Validation, Quality Engineering, Manufacturing Compliance, Computer System Validation, or a related pharmaceutical function.
- Hold a bachelor's degree or higher in Pharmaceutical Sciences, Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Biomedical Engineering, Life Sciences, Engineering, or a related discipline.
- Have experience supporting validation and qualification activities in regulated pharmaceutical or biotechnology environments.
- Have experience with process validation, cleaning validation, equipment qualification, facility qualification, or computerized system validation.
- Have strong knowledge of FDA regulations, GMP requirements, and relevant ICH guidelines.
- Be familiar with data integrity principles, 21 CFR Part 11 requirements, and risk-based validation approaches.
- Have experience reviewing validation documentation, protocols, reports, and compliance records.
- Demonstrate strong analytical, research, and problem-solving skills.
- Have excellent written English communication skills.
- Be able to work independently and follow detailed review instructions.
- Be comfortable with a task-based freelance engagement model and variable assignment availability.
Responsibilities
- Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency, and compliance with industry standards.
- Review content related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
- Assess whether AI-generated conclusions are supported by scientific principles, regulatory expectations, and industry best practices.
- Identify unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
- Reference FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices to validate information.
- Explain findings and recommend technically accurate corrections.
- Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
- Complete independent evaluations on designated online platforms within established project timelines.
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