GMP Compliance & Validation Subject Matter Expert -AI Model Evaluation
Volga Partners
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Job summary
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.
Qualifications
- 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.
Responsibilities
- 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.
Skills
Education
Job description
Remote | United States | Project-Based Independent Contractor
Compensation: $20-$50 USD/hour, based on specialty, experience, and project requirements
What if your expertise in Pharmaceutical GMP compliance, validation programs, qualification activities, and regulatory requirements could help artificial intelligence better understand pharmaceutical manufacturing controls, validation standards, and inspection readiness expectations?
At Volga Partners, we're connecting experienced pharmaceutical professionals with opportunities to contribute to the development and evaluation of advanced AI models.
We're seeking experienced Pharmaceutical GMP Compliance and Validation professionals who can apply their compliance expertise, technical knowledge, and industry experience to evaluate AI-generated pharmaceutical content.
This isn't a traditional validation or compliance position. You won't be executing validation protocols, leading qualification activities, managing compliance programs, or supporting regulatory inspections. Instead, you'll evaluate complex compliance and validation-related content, identify technical inaccuracies, assess regulatory reasoning, and provide structured feedback that improves AI model performance.
Your pharmaceutical expertise is what matters. AI experience is a plus, not a requirement.
Important Note: This is a freelance, task-based role designed for those seeking supplemental income. It's essential to understand the nature of freelance work—tasks will be assigned as they become available, and work may be irregular or intermittent.
As a GMP Compliance & Validation Subject Matter Expert (SME), you'll serve as a subject matter evaluator, helping assess the quality, accuracy, completeness, and regulatory compliance of Pharmaceutical AI-generated content.
You'll analyze validation, quality, manufacturing, engineering, compliance, and inspection-readiness scenarios, identify errors or unsupported conclusions, and provide expert feedback grounded in GMP regulations, validation principles, and pharmaceutical industry best practices.
Your contributions will help improve how AI systems understand and respond to complex compliance, qualification, and validation challenges across regulated pharmaceutical environments.
- 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.
Apply Your Industry Expertise in a New Way
Use the knowledge you've developed throughout your pharmaceutical or biotechnology career to contribute to advanced AI technologies.
Help Improve Scientific Accuracy
Your evaluations will help strengthen the quality and reliability of AI-generated pharmaceutical and regulatory information.
Work Remotely
Participate in project-based assignments from an eligible location, with flexibility based on project needs and availability.
Explore the Future of Pharmaceutical Technology
Gain experience contributing to AI evaluation initiatives while applying your existing scientific and regulatory expertise.
No AI Background Required
We're looking for professionals who can recognize accurate scientific reasoning, identify errors, and communicate expert assessments with clarity.
Compensation:
Volga Partners offers project-based hourly compensation based on specialization, relevant experience, professional qualifications, geographic location, and assignment requirements.
GMP Compliance & Validation Subject Matter Expert: $25-$50 USD/hour
Compensation may vary based on experience level, area of expertise, and task complexity.
- Engagement Type: Project-based independent contractor
- Work Arrangement: Remote
- Primary Location: United States preferred
- Additional Markets: Professionals outside the United States may be considered if they possess substantial U.S. pharmaceutical industry experience
- Schedule: Variable and assignment-based
- Project Type: Pharmaceutical AI content evaluation
- Project Duration: Based on project requirements and assignment availability
- Selection Process: Qualified candidates may be required to complete screening questions and evaluation exercises prior to project selection
Specific assignments, schedules, workloads, and project dates will be communicated as they are confirmed. Hours and future assignments are not guaranteed.
If you're an experienced pharmaceutical or biotechnology professional who enjoys analyzing complex scientific information, applying regulatory and technical expertise, and contributing to innovative technology, we'd love to hear from you.
Join Volga Partners and help shape the next generation of pharmaceutical AI.
We're seeking experienced GMP Compliance and Validation professionals who bring practical industry expertise and are comfortable reviewing technical information, exercising independent judgment, and clearly explaining their conclusions.
- Minimum of 5 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
We encourage applications from professionals with backgrounds such as:
- PharmD, MS, MBA, PhD, or other advanced scientific credentials
- Experience leading process validation or cleaning validation programs
- Expertise in IQ/OQ/PQ protocol development and execution
- Experience supporting FDA, EMA, MHRA, or other regulatory inspections
- Knowledge of Annex 11, GAMP 5, and Data Integrity requirements
- Experience with Continued Process Verification (CPV) programs
- Experience performing compliance assessments, gap analyses, and remediation activities
- Experience collaborating with Manufacturing, Quality Assurance, Engineering, Regulatory Affairs, and Technical Operations teams
- Experience with technical writing, validation documentation review, or compliance assessments
- Familiarity with AI evaluation, data annotation, or quality review activities
Experience with AI model evaluation, large language models (LLMs), research, or structured quality assessments is beneficial but not required.
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