Deputy General Manager, Quality Management Systems

You will be responsible for the following tasks as part of the role: - Execution of WL Protocol at each site - Reviewing the outcomes of protocol-based studies as outlined in the FDA commitment - Conducting protocol-based retrospective reviews of investigations (deviations, OOS and OOAL) of product batches within shelf life - Conducting protocol-based retrospective reviews of investigations related to market complaints - Developing a protocol for Material system assessment and suitability of vendors and implementing enhanced processes at all sites - Reviewing high-risk Investigation reports before batch disposition - Categorizing defects in the Visual Inspection program as critical, major, and minor - Implementing SOP on QRM for Injectable product Defect across all Amneal sites - Developing a protocol for assessment for QU authority and resources and implementing enhanced processes across all sites - Creating a protocol for assessment of laboratory practices, procedures, methods, equipment, documentation, and analyst competencies - Reviewing Microbiological excursions (Media fill, EM excursion, BET test, MLT failures) - Developing a protocol for assessment of documentation systems used throughout manufacturing and laboratory operations to determine where documentation practices are insufficient - Owning process compliance, standardization, capability, training/competency, and continuous improvement - Ensuring audit/inspection readiness - Establishing and monitoring global KPIs (e.g., investigation cycle time, overdue investigations, repeat events, CAPA effectiveness) and providing metrics and insights for Quality Management Review (QMR) - Implementing a roadmap and tools to ensure consistency in root cause analysis (5-Why, Ishikawa, FMEA, DMAIC, etc.) - Identifying and implementing process simplification, digitization, and automation opportunities - Promoting knowledge sharing across sites through Communities of Practice - Acting as the single point of accountability for the investigation process globally Please note that Amneal is an equal opportunity employer that values diversity and inclusion. They do not discriminate based on caste, religion, gender, disability, or any other legally protected status.,