Pharmaceutical Quality Assurance Subject Matter Expert – AI Model Evaluation

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

📋 Description

• Assess the accuracy, completeness, consistency, and adherence to industry standards of AI-generated pharmaceutical content.

• Examine scientific and regulatory data related to quality systems, manufacturing processes, validation, submissions, development, and compliance activities.

• Evaluate whether conclusions drawn from AI outputs are aligned with scientific principles, regulatory expectations, and industry best practices.

• Detect unsupported assertions, technical inaccuracies, absent context, and flawed reasoning.

• Reference FDA guidelines, GMP regulations, ICH standards, and accepted practices within the pharmaceutical industry.

• Deliver expert feedback, clarify findings, and propose technically accurate modifications.

• Utilize project-specific evaluation criteria, scoring guidelines, and quality benchmarks.

• Conduct independent assessments using designated online platforms while adhering to project timelines.

⛳️ Requirements

• At least 4 years of experience in pharmaceutical Quality Assurance.

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

• Experience in GMP-regulated settings.

• Knowledge of Quality Management Systems (QMS), Corrective and Preventive Actions (CAPA), deviations, and change control processes.

• Strong analytical and technical review capabilities.

• Ability to critically assess technical and regulatory documentation.

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

• Outstanding written English communication skills.

• Capacity to work independently while adhering to detailed review instructions.

• Comfort with a freelance engagement model focused on task-based work.

• Experience in leading Quality Systems is preferred.

• Familiarity with inspection readiness is preferred.

• Experience in supplier quality management is preferred.

• ASQ certification or equivalent quality credentials are preferred.

• Experience in managing post-approval changes and variations is preferred.

• Technical writing or document review experience is preferred.

• Familiarity with AI evaluation, data annotation, or quality review tasks is preferred.

• Experience with AI model assessments, large language models (LLMs), research, or structured quality evaluations is beneficial but not mandatory.

🏝️ Benefits

• Opportunity for remote work.

• Flexible schedule based on assignments.

• Project-based tasks ideal for supplemental income.

• Chance to contribute to cutting-edge AI technologies.

• Experience in AI evaluation initiatives.

• No prior AI experience is necessary.