Global Serialization Operations Specialist in Hyderabad, भारत

Amgen seeks a Global Serialization Operations Specialist to manage pharmaceutical serialization compliance and traceability operations across multiple regions in a structured shift model. The role requires exception management, EU FMD execution, product identifier data maintenance, and coordination with quality, sites, and logistics partners to ensure inspection readiness.

Responsibilities

• Manage global serialization exceptions across US, EU, MEA, and JAPAC with triage, coordination, and closure
• Execute EU FMD operational processes, monitor alerts, and coordinate investigations and reprocessing activities
• Maintain Product Identifier Database accuracy and support US customer setup for DSCSA requirements
• Ensure inspection readiness through case documentation, process evidence, training records, and audit trails
• Partner with regional process owners, Quality, and logistics partners to resolve complex operational issues and identify process improvements

Requirements

• Bachelor's degree in Supply Chain, Life Sciences, Pharmacy, Engineering, or related field
• 5–9 years pharmaceutical supply chain, serialization, quality operations, or regulatory reporting experience
• Hands-on experience with serialized-product exception management, data investigation, and controlled documentation
• Knowledge of EU FMD; familiarity with US DSCSA, MEA, or JAPAC requirements preferred
• Understanding of GxP principles, data integrity, change control, and inspection-readiness requirements
• Strong written English; ability to communicate with global teams, sites, and quality stakeholders
• Ability to work in structured shift model with disciplined handovers and time-sensitive escalation