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Job Description
- In this role, you will be responsible for supporting daily DSCSA operations, which includes overseeing product serialization, traceability, and exception handling. You will collaborate with internal teams such as QA, IT, and Logistics, as well as external partners like CMOs, 3PLs, and wholesalers to ensure the accurate exchange of product data.
Your key responsibilities will involve monitoring and investigating DSCSA compliance issues, such as "data no product" and "product no data" exceptions, and ensuring the precise and timely submission of T3 data (Transaction Information, Transaction History, and Transaction Statement). Additionally, you will be required to reconcile all outbound shipments from the 3PL using the middleware system to guarantee compliance with DSCSA guidelines.
Furthermore, you will be expected to maintain detailed records of DSCSA-related activities in adherence to FDA regulations. You will also play a vital role in assisting with system testing, documentation, and the implementation of serialization and verification solutions, such as EPCIS and VRS. It will be essential for you to stay informed about the latest FDA DSCSA regulations and industry best practices.
Moreover, you will be actively involved in participating in audits, inspections, and readiness exercises to ensure compliance and preparedness. This role will require a high level of attention to detail, strong organizational skills, and the ability to work effectively both independently and collaboratively with various stakeholders.,
Skills
TestingException HandlingTraceabilityInspectionsDocumentationCompliance MonitoringProduct SerializationVRSSystem TestingAuditsReconciliationRegulatory ComplianceT3 Data SubmissionFDA RegulationsEPCISData ExchangeImplementationIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
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