Senior Associate QA, International Distribution Quality in Hyderabad, भारत

Amgen seeks a Senior Associate QA for its International Distribution Quality team in Hyderabad. The role involves overseeing global product distribution, managing quality events and compliance, and ensuring adherence to GMP/GDP standards across the supply chain.

Responsibilities

• Implement QA oversight of global product distribution and transportation from supply hubs to markets
• Manage quality events, change controls, corrective and preventive actions, and distribution complaint triage
• Assess and manage temperature excursion and distribution deviation impacts on product quality
• Conduct internal audits, self-inspections, and support external audit/inspection activities
• Collaborate with third parties and service providers to ensure compliance and performance improvement

Requirements

• Bachelor's degree in science or engineering with 7+ years related professional experience
• Understanding of GMP/GDP requirements and pharmaceutical regulations
• Familiarity with logistics processes including parcel, transport, and warehousing
• Experience in validation and qualification of processes, equipment, and facilities
• Strong technical writing and communication skills
• Analytical and problem-solving capabilities with continuous improvement mindset