About the Role
We are looking for a consultant who will focus on validating and testing AI/ML-enabled systems that are used in highly regulated industries (such as pharmaceuticals and life sciences). These systems must follow strict compliance guidelines like GxP/GMP standards.
The role ensures that whenever AI, Machine Learning, or automation features are added to existing systems or when new platforms are integrated these solutions are trustworthy, reliable, and compliant with regulations.
Key
AI/ML System Validation
- Test and validate AI/ML models to ensure accuracy, fairness, and compliance.
- Apply methods like confusion matrices, precision, recall, F1 scores, and other metrics to check model performance.
- Validate both traditional ML models and LLM (Large Language Models) or RAG (Retrieval-Augmented Generation) systems.
Compliance & Regulatory Testing
- Design and execute validation strategies that meet GxP/GMP regulatory requirements.
- Ensure that AI/ML-enabled systems in regulated environments are transparent, auditable, and safe.
Integration Testing
- Test new components and features being added to existing platforms.
- Ensure integrations (AI tools, ML models, or rule-based systems) work smoothly and produce correct outputs.
Data Validation & Engineering Support
- Validate the quality, consistency, and reliability of data pipelines and data inputs used by AI/ML models.
- Collaborate with data engineering teams to ensure clean and compliant data flows.
End-to-End Output Validation
- Confirm that the final system outputs are accurate, explainable, and compliant with business/regulatory requirements.
- Document results in a clear and structured way for auditors and stakeholders.
Required Skills
- Understanding of Machine Learning concepts (classification, regression, confusion matrix, etc.).
- Knowledge of LLMs, RAG, and AI validation techniques.
- Familiarity with GxP/GMP compliance standards or regulated IT environments.
- Strong skills in data engineering concepts (data pipelines, data quality checks).
- Ability to design test strategies and document validation evidence.
Nice to Have
- Experience with cloud-based ML/AI platforms.
- Familiarity with rule-based systems and their validation.
- Strong analytical and problem-solving skills.