Manager / Senior Manager - Field Alert Report

As a Corporate Quality professional at Amneal, you will play a crucial role in bridging communication between departments, CMOs, and sites for writing, tracking, and reporting of events. Your primary responsibility will include ensuring timely submission of Field Alerts (FAR/BPDR) and Illegitimate Drug Notifications to FDA. You will act as an author, coordinator, and issuer as required, while also being responsible for identifying potential issues that may require reporting to FDA. Your role will involve assessing emerging trends and issues that could impact Amneal's compliance, customer experience, or reputation. You will provide support and leadership in determining and implementing CAPAs to prevent recurrence of issues across different sites and product lines. Working in a dynamic environment, you will collaborate with cross-functional teams to process reportable events compliantly and within set timelines. Additionally, you will maintain dashboards, monitor adverse trends, and ensure all necessary documentation is up to date. - Recognize and report preexisting or potential issues warranting submission of Field Alert or Illegitimate Drug Notification forms to FDA. - Advise quality management on emerging trends and issues that may affect compliance, customer experience, or company reputation. - Determine and implement CAPAs from Field Alert investigations to prevent recurrence across sites and product lines. - Independently and collaboratively process reportable events in a compliant manner and within defined timelines. - Maintain dashboards, assess for reportable conditions, and monitor adverse trends. - Partner with cross-functional teams to create, monitor, and submit Field Alerts forms. - Keep track of all necessary documentation and communicate timelines effectively. - Write and maintain SOPs in line with regulatory and Amneal procedural requirements. Qualifications: - Master's Degree,