GMP Compliance & Validation SME: AI Content Evaluator (Remote)

Volga Partners; United States; Teletrabalho; USD 28 000 - 69 000; Tempo parcial

Resumo da oferta

Volga Partners is seeking experienced GMP Compliance and Validation professionals to act as subject-matter evaluators for AI-generated pharmaceutical content. This freelance, project-based role focuses on analyzing regulatory and technical information rather than performing traditional validation activities.

You will review accuracy, regulatory alignment, and data integrity, providing structured expert feedback.

Qualificações

• Minimum 5 years of professional experience in GMP Compliance, Validation, Quality Engineering, Manufacturing Compliance, Computer System Validation, or related pharmaceutical functions.
• 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.

Responsabilidades

• Evaluate AI-generated pharmaceutical content: Assess scientific, technical, and regulatory responses for accuracy, completeness, consistency, and compliance with industry standards.
• Review scientific and regulatory information: Examine content related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
• Analyze technical reasoning: Determine whether AI-generated conclusions are supported by relevant scientific principles, regulatory expectations, and industry best practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
• Validate information: Reference relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Provide expert feedback: Clearly explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
• Support AI quality improvement: Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
• Complete independent evaluations: Use designated online platforms to complete assignments accurately and within established project timelines.

Conhecimentos

GMP Compliance

Validation

Quality Engineering

Manufacturing Compliance

Computer System Validation

FDA regulations

GMP requirements

ICH guidelines

Data integrity

21 CFR Part 11

Risk-based validation

Documentation review

Analytical skills

Written English communication

Independent work

Freelance engagement

Formação académica

Bachelor's degree or higher in Pharmaceutical Sciences, Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Biomedical Engineering, Life Sciences, Engineering

Descrição da oferta de emprego

Volga Partners is seeking experienced GMP Compliance and Validation professionals to act as subject-matter evaluators for AI-generated pharmaceutical content. This freelance, project-based role focuses on analyzing regulatory and technical information rather than performing traditional validation activities.

You will review accuracy, regulatory alignment, and data integrity, providing structured expert feedback.