Pharmaceutical Quality Assurance Subject Matter Expert - AI Model Evaluation
V
Volga PartnersPharmaceutical quality assurance
Remote | United States | Project-Based Independent Contractor; Primary Location: United States preferred; Professionals outside the United States may be considered if they possess substantial U.S. pharmaceutical industry experienceContractMiddle
Salary20 - 50 USD per hour
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Job Details
- Languages
- Excellent written English communication skills
- Experience
- Minimum 4 years of pharmaceutical QA experience
Requirements
- Have a minimum of 4 years of pharmaceutical QA experience.
- Hold a bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related discipline.
- Have experience working in GMP-regulated environments.
- Understand QMS, CAPA, deviations, and change control systems.
- Demonstrate strong analytical and technical review skills.
- Be able to critically evaluate technical and regulatory information.
- Have strong research and problem-solving skills.
- Have excellent written English communication skills.
- Be able to work independently and follow detailed review instructions.
- Be comfortable working within a task-based freelance engagement model.
- Quality Systems leadership, inspection readiness, supplier quality management, or post-approval changes and variations experience is preferred.
- ASQ certification or equivalent quality credentials, technical writing or document review experience, and familiarity with AI evaluation or data annotation are preferred.
Responsibilities
- Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency, and compliance with industry standards.
- Review scientific and regulatory information 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.
- Validate information against relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
- Explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
- Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
- Complete independent evaluations on designated online platforms accurately and within project timelines.
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