Global Serialization Operations Specialist

Amgen; Hyderabad; In loco; INR 1.200.000 - 1.800.000; Tempo pieno

Descrizione del lavoro

Amgen is seeking a Global Serialization Operations Specialist to ensure compliant, timely serialization across US, EU, MEA and JAPAC with a shift-based coverage model.

You will manage EU FMD processes, PID activities, and US DSCSA customer setup while coordinating with regional teams to sustain inspection readiness and continuous improvement in global operations.

Competenze

• 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.
• Familiarity with SAP ATTP, TraceLink, SAP ICH, EPCIS, GS1 standards and related tools.
• Strong written English and stakeholder communication across global teams.
• Understanding of GxP, data integrity, change control, deviations, and inspection readiness.

Mansioni

• 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.

Conoscenze

Stakeholder communication

Technical writing

Attention to detail

Root-cause analysis

Ownership

Formazione

Bachelor's degree in Supply Chain, Life Sciences, Pharmacy, Engineering, Information Systems or a related discipline

Strumenti

SAP ATTP

TraceLink

SAP ICH

EPCIS

GS1 standards

Descrizione del lavoro

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 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen