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Description:

The role will assist with day-to-day logistics and distribution processes that support Amneal's transition to meet FDA DSCSA requirements and assigned milestones. Reporting to the Business Process Manager, this position will collaborate with various departments to help maintain processes and measures that support compliance with DSCSA. The primary focus is to ensure Amneal's serialization activities are carried out in alignment with current DSCSA regulations and prepared for future manufacturing rules and regulations.

Essential Functions:

+ Maintain and continuously improve business processes impacted by serialization operations, ensuring compliance with regulatory requirements, data integrity, and operational efficiency. Monitor system performance, identify process gaps, coordinate with cross-functional teams, assist in collecting data to support the determination of corrective actions, and document updates to support traceability, product authentication, and supply chain security.

+ Troubleshoot and resolve transaction errors within established KPIs for distribution centers and customers by assisting in identifying root causes, coordinating with internal teams and external partners, and assist in troubleshooting corrective actions.

+ Ensure timely resolution to minimize operational disruptions, maintain inventory accuracy, and support on-time order fulfillment, while documenting issues and solutions to drive process improvements and prevent recurrence.

+ Support cross-functional project efforts by collaborating with business partners and delivery teams to identify appropriate solutions aligned with business needs.

+ Contribute to the development and maintenance of Standard Operating Procedures (SOPs) related to DSCSA, ensuring updates follow established guidelines and review processes. Assist in coordinating implementation activities, helping to align project milestones and interdependencies within broader plans to ensure successful delivery.

+ Assist with carrying out new serialization requirements in alignment with the DSCSA timeline, under the guidance of the Business Process Manager.

+ Support User Acceptance Testing by working with the business and help define test scope, scenarios to be tested, identify areas of impact requiring regression testing, etc.

+ Document and review the information needs of the business, and assist in supporting the delivery of appropriate solutions under established processes.

Additional Responsibilities:

+ Partner with business clients and delivery teams to determine appropriate solutions Conduct risk assessment against the user requirements

+ Assist in the development of detailed work practices/user documentation and training

+ Manage the project implementation activities and ensure that the solution delivered meets the business requirements Coordinate with project management counterparts to plan project schedules, timeliness and deliverables to insure alignment of US and International deliverables