Logistics Quality Specialist

2 days ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878

At Amgen, we are dedicated to supporting your professional and personal growth, and well-being.

  • About the Role:

This position is responsible for ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). The Quality Assurance Contact will oversee quality events, change control records, corrective and preventive actions, and distribution complaints. They will also collaborate with third-party vendors to ensure service level alignment and support logistics providers.

Key Responsibilities:
  • Perform QA tasks on quality events, change control records, CAPAs, and distribution complaints
  • Work closely with all relevant partners to ensure end-to-end process compliance with GMP/GDP
  • Act as a subject matter expert for transportation-related Quality Processes
  • Collaborate with 3rd parties to ensure alignment with service levels and identify opportunities for performance improvement
  • Prepare, review, and approve SOPs and other GMP/GDP documentation
  • Risk management strategies to mitigate potential risks in the supply chain
  • Provide oversight for logistics service providers and transportation service providers
  • Support internal/external audits and inspections
  • Provide quality expertise and guidance to operational staff and cross-functional teams
Required Skills and Qualifications:
  • Bachelor's degree in Science or Engineering and 2+ years of professional experience in related fields
  • Understanding of GMP/GDP requirements and their application in pharmaceutical logistics
  • Familiarity with logistics processes for parcel, transport, and warehousing providers
  • Experience in validation/qualification of processes, equipment, and facilities
  • Strong technical writing skills, with experience drafting and reviewing documentation
  • Independent, self-starter with ability to work autonomously under pressure and within teams
  • Knowledge of GMP/GDP and pharmaceutical regulations
What You Can Expect from Us:
  • A collaborative culture that encourages continuous learning and career development
  • Opportunities for professional growth within a leading biopharmaceutical company

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