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

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 Ahmedabad (India)
🏢 Amneal
📍 India