Global Serialization Operations Specialist
Amgen · Hyderabad
Career Category
EngineeringJob 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 clear 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 complex operational issues.
- Identify process gaps and recurring deviations; contribute to corrective actions, global playbooks, knowledge management and process standardization.
- Support serialization inspections, audits, recalls and significant supply events through prompt, accurate and compliant operational coordination.
- Contribute operational expertise to S/4HANA, ICH and future platform initiatives, including process design, testing and deployment readiness.
Key outcomes
- Timely and compliant resolution of serialization exceptions across US, EU, MEA and JAPAC.
- Reliable execution of EU FMD reporting, alert monitoring and reprocessing activities.
- Accurate and controlled PID maintenance and effective US DSCSA customer setup support.
- Sustained inspection readiness with clear, retrievable evidence of process execution.
- Reliable shift coverage and seamless handover between global operations teams.
- Reduced recurrence of operational issues through root-cause management, standardization and continuous improvement.
- Strong operational input into the future S/4HANA and ICH platform model.
Qualifications – Global Serialization Operations Specialist (AIN)
- Bachelor’s degree in Supply Chain, Life Sciences, Pharmacy, Engineering, Information Systems or a related discipline.
- 5–9 years of experience in pharmaceutical supply chain, serialization/traceability, quality operations, regulatory reporting or technical services.
- Experience with serialized-product processes, including exception management, data investigation, reconciliation and controlled documentation.
- Knowledge of EU FMD; exposure to US DSCSA, MEA or JAPAC traceability requirements is preferred.
- Familiarity with SAP ATTP, TraceLink, SAP ICH, EPCIS, GS1 standards, Product Identifier Data and/or case-management tools is preferred.
- Understanding of GxP principles, data integrity, change control, deviation/investigation management and inspection readiness.
- Able to interpret operational data, identify trends and support root-cause analysis and corrective actions.
- Strong written English and clear stakeholder communication across global teams, sites, affiliates, LSPs and Quality.
- Comfortable working in a defined shift structure, including disciplined handovers and time-sensitive escalation of critical events.
- Demonstrated attention to detail, ownership, prioritization and ability to work independently in a controlled, high-compliance environment.
- Technical writing experience for SOPs, work instructions or process documentation is preferred.