Description

Key Responsibilities

- Develop and implement AI/ML models for data extraction, validation, and analysis (documents, chromatograms, lab data)
- Build NLP-based solutions for semantic search, document processing, and structured data generation
- Implement AI-driven anomaly detection, trend analysis, and predictive insights
- Enable AI use cases across MVS, LIMS, ELN, QMS, and Excel validation systems
- Evaluate and validate vendor AI solutions:
- Verify accuracy, reliability, and performance
- Design validation scenarios and test datasets
- Review model logic and outputs
- Identify risks, gaps, and compliance issues

- Support system integration (LIMS, ELN, QMS, SAP) and data harmonization
- Ensure compliance with GxP, Data Integrity (ALCOA+), and 21 CFR Part 11
- Support Computer System Validation (CSV) and audit readiness

Required Skills

- Solid programming in Python
- Experience in Machine Learning & AI model development
- Knowledge of NLP (document extraction, semantic search)
- Exposure to OCR / data extraction from PDFs
- Experience with TensorFlow / PyTorch




- Understanding of model validation, statistics, and data analysis
- Basic knowledge of APIs and system integration

Preferred Domain Knowledge

- Exposure to LIMS, ELN, QMS, SAP, or MVS systems
- Understanding of Method / Analytical Validation
- Experience in Excel validation / CSV processes
- Knowledge of GxP and Data Integrity

Experience & Qualification

- Minimum 3 years of AI/ML experience
- Pharma / Healthcare domain preferred
- Degree in AI / Data Science / Computer Science
OR Pharma background with AI experience

Key Competencies

- Strong analytical and problem-solving skills
- Ability to evaluate and challenge vendor solutions
- Good communication and documentation skills
- Comfortable working in a regulated environment

Qualifications
Education:

- B. Pharm B. Pharm - Required

- M. Pharm M. Pharm - Preferred

Experience:

- 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

📌 Executive, R&D Injectable (AI/ML) (Ahmedabad)
🏢 Amneal
📍 Ahmedabad