Assistant Manager -Investigations (SIT)

Designation: Assistant Manager - Investigations (SIT)

Office Location: Chhatrapati Sambhajinagar

Primary Responsibilities: Review and evaluate Root CauseAnalyses (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 technicalevaluation of investigation findings to ensure robust root causeidentification, effective CAPAs, and sustained product quality and compliance.

Review and develop a thoroughunderstanding of product development reports, analytical method validationreports, and supporting scientific documentation.

Conduct detailed reviews ofmanufacturing operations for respiratory and oral solid dosage products,including process equipment, batch manufacturing records, Critical ProcessParameters (CPPs), Critical Material Attributes (CMAs), and Critical Quality Attributes(CQAs).

Review and understand QualityControl laboratory operations involving analytical instruments such as HPLC,GC, UV-Visible Spectrophotometers, and other laboratory systems, includingassessment of analytical raw data and laboratory investigations.

Ensure adherence to currentregulatory requirements and quality compliance standards, while maintainingawareness of evolving global regulatory guidelines and industry best practices.

Apply statistical tools and dataanalysis techniques using Minitab software to support trend analysis, processcapability assessments, investigation activities, and continuous improvementinitiatives.

Required work experience

• Industry: Pharmaceutical
• Years of experience: 12-15 years