About The Role

Designation: Assistant Manager - Investigations (SIT) Office Location: Chhatrapati Sambhajinagar Primary Responsibilities: § Review and evaluate Root Cause Analyses (RCA) associated with OOS (Out of Specification), OOT (Out of Trend), incidents, CAPAs, and Product Market Complaints for Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI), Nasal Sprays, Foams, and Oral Solid Dosage (OSD) formulations. § Provide scientific and technical evaluation of investigation findings to ensure robust root cause identification, effective CAPAs, and sustained product quality and compliance. § Review and develop a thorough understanding of product development reports, analytical method validation reports, and supporting scientific documentation. § Conduct detailed reviews of manufacturing operations for respiratory and oral solid dosage products, including process equipment, batch manufacturing records, Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), and Critical Quality Attributes (CQAs). § Review and understand Quality Control laboratory operations involving analytical instruments such as HPLC, GC, UV-Visible Spectrophotometers, and other laboratory systems, including assessment of analytical raw data and laboratory investigations. § Ensure adherence to current regulatory requirements and quality compliance standards, while maintaining awareness of evolving global regulatory guidelines and industry best practices. § Apply statistical tools and data analysis techniques using Minitab software to support trend analysis, process capability assessments, investigation activities, and continuous improvement initiatives. Required work experience Industry: Pharmaceutical Years of experience: 12-15 years