Job Description

WL Protocol Execution at each site Review of outcome of protocol-based studies as outlined in the FDA commitment. Protocol based retrospective review of investigations (deviations, OOS and OOAL) of product batches within shelf life. Protocol based Retrospective review of investigations related to market complaints. Protocol for Material system assessment and suitability of vendors. Implement enhanced process at all sites. Review of high-risk Investigation reports before batch disposition Visual Inspection program - Defect categorization for critical, major, and minor defects. Implement SOP on QRM for Injectable product Defect across all Amneal sites. Protocol for assessment for QU authority and resources. Implement enhanced process across all sites. Protocol for assessment of laboratory practices, procedures, methods, equipment, documentation, and analyst competencies Review of Microbiological excursions (Media fill, EM excursion, BET test, MLT failures) Protocol for assessment of documentation systems used throughout manufacturing and laboratory operations to determine where documentation practices are insufficient Ownership - Process compliance, standardization, capability, training/competency, and continuous improvement Oversees audit/inspection readiness Establishes and monitors global KPIs (e.g., investigation cycle time, overdue investigations, repeat events, CAPA effectiveness). Provides metrics and insights for Quality Management Review (QMR). Implement roadmap and tools to ensure consistency in root cause analysis (5-Why, Ishikawa, FMEA, DMAIC, etc.). Identifies and implements process simplification, digitization, and automation opportunities. Promotes knowledge sharing across sites through Communities of Practice Acts as the single point of accountability for the investigation process globally.



Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.