Executive, R&D Injectable (AI/ML)

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 - 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: