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Hiring companyAmgen
Verified today
Senior Associate Quality Assurance
Hyderabad, India Full-time On-site
About the role
Senior Associate QA responsible for quality oversight of Amgen’s external supply portfolio, partnering with cross‑functional teams to ensure GMP/GDP compliance, audit support, SOP review, risk management, and continuous improvement initiatives.
What you’ll do
- Perform QA contact for partners, ensuring quality agreement adherence.
- Assess partners for change control and deviation records.
- Support partnership alliance quality tasks, document revisions, audits.
- Assist portfolio strategy execution, due diligence.
- Collaborate with cross‑functional teams for GMP/GDP compliance.
- Review and approve SOPs and GMP/GDP documentation.
- Engage external suppliers and partners.
- Integrate risk management into supply lifecycle.
- Support internal/external audit and inspection activities.
- Lead operational improvement initiatives.
- Develop practical solutions aligned with objectives.
- Own business metrics and performance assessments.
- Work independently under minimal supervision.
What you’ll bring
Master’s/Bachelor’s, 1-5 yrs quality, GMP/GDP, supplier oversight, technical writing.
Nice to have
Lean, continuous improvement, supply chain, project mgmt, analytical, self‑starter, GMP/GDP, MS Office.
Skills
Quality AssuranceGMPGDPSupplier ManagementTechnical WritingAlliance ManagementRisk ManagementAudit SupportProcess ImprovementLeanProject ManagementAnalytical ThinkingMicrosoft Office
Education
Bachelor