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Hiring companyAmgen
Verified today
Senior Associate QA, Global Distribution Quality
Hyderabad, India Full-time On-site
About the role
Senior Associate QA in Amgen’s Global Distribution Quality team ensures compliance with GMP/GDP across global supply chain. Leads QA oversight of product distribution, transportation, and logistics. Manages QA events, change control, CAPA, and complaints. Prepares and approves SOPs and regulatory documentation. Acts as SME for transportation quality processes, collaborates with 3rd parties, and drives performance improvement. Supports audits, inspections, and operational improvement initiatives. Provides quality guidance to cross‑functional teams and owns supplier metrics. Works independently with minimal supervision.
What you’ll do
- Implement and oversee global product distribution and transportation
- QA oversight of Global Supply Chain operations
- Perform QA contact on events, change control, CAPA, complaints
- Ensure compliance to GMP/GDP
- SME for transportation quality processes
- Collaborate with 3rd parties on service levels, performance improvement
- Prepare, review, approve SOPs and GMP/GDP documentation
- Incorporate risk management into supply chain strategy
- Support logistic and transportation service provider oversight
- Assist audit/inspection teams
- Provide quality guidance to operational staff and cross‑functional teams
- Drive operational improvement initiatives, programs, projects
- Own supplier metrics, performance assessments
- Work independently with minimal supervision
What you’ll bring
- Bachelor's in science/engineering + 2+ yrs experience in related fields
- GMP/GDP knowledge and regulatory understanding
- Logistics experience with parcel, transport, warehousing providers
- Validation/Qualification of processes, equipment, facilities
- Technical writing, documentation, SOP review
- Independent self‑starter, autonomous, under pressure
- Strong communication across all levels, written & verbal
- Microsoft Office proficiency (Excel, Word, PowerPoint)
- Multi‑tasking, prioritization, change‑management skills
Skills
QAGMPGDPLogisticsValidationQualificationTechnical WritingSOPRisk ManagementAuditInspectionTransportationSupplier MetricsProcess ImprovementChange ManagementCommunicationMicrosoft OfficeExcelWordPowerPoint
Education
Bachelor