13 Oct
|
AMGEN
|
Hyderabad
Career Category
Engineering
Job Description
Delivers compliant, timely and inspection-ready global serialization operations across the US, EU, MEA and JAPAC.
The role operates in a structured, multi-region shift model, providing run-with-the-sun coverage through transparent handovers and coordinated support across time zones. It combines hands-on exception management, EU FMD execution, PID activities, US customer setup and technical-services support.
Working closely with regional process owners, Quality, affiliates, sites, LSPs and technology partners, the Specialist ensures reliable end-to-end execution and operational continuity.
Key responsibilities
• Manage day-to-day global serialization exceptions across US, EU, MEA and JAPAC, ensuring timely triage, coordination, escalation, follow-up and closure.
• Execute EU FMD operational processes in accordance with approved procedures, work instructions and training requirements.
• Monitor EU FMD reporting and alerts, including investigation coordination, reprocessing, stakeholder communication and timely case closure.
• Execute and maintain Product Identifier Database (PID) activities, ensuring accurate, controlled and timely product-identifier data.
• Support US customer setup activities for DSCSA serialization and traceability requirements.
• Provide technical-services support, including change-control coordination and technical writing for controlled procedures, work instructions and process documentation.
• Maintain inspection readiness through complete case documentation, process evidence, training records, KPI reporting and clear audit trails.
• Provide support within a structured global shift model, ensuring effective handovers, prioritization of critical events and continuity of operations.
• Monitor service performance, case ageing, alert-resolution timelines, right-first-time execution and recurring root causes.
• Partner with regional process owners, Quality, affiliates, sites, LSPs and technical teams to resolve
📌 Global Serialization Operations Specialist (Hyderabad)
🏢 AMGEN
📍 Hyderabad