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Senior Associate Qa, International Affiliates

7-9 years
Not Disclosed
10 Dec. 14, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here’s a polished and concise version of the Quality Assurance Specialist – Supply Chain Support job description for Amgen:


Position: Quality Assurance Specialist – Supply Chain Support

Department: Quality Assurance (QA)
Location: Amgen India


About Amgen

At Amgen, we’re united by a mission to serve patients living with serious illnesses. Since 1980, we’ve pioneered breakthroughs in biotechnology, delivering innovative medicines across Oncology, Inflammation, General Medicine, and Rare Disease.

Join our collaborative, science-driven, and award-winning culture to make a lasting impact on lives worldwide while transforming your career.


Role Overview

In this critical role, you will collaborate with global quality teams, manufacturing sites, supply chains, and external partners to ensure compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). As a QA Specialist, you will uphold quality standards across product complaints, distribution processes, and quality events, ensuring a reliable supply chain for Amgen products.


Key Responsibilities

Quality Record Management

  • Serve as QA contact for product complaints, distribution complaints, and temperature excursion records.
  • Manage quality records for complaints, recalls, and returned goods, ensuring compliance with regulatory and internal standards.
  • Ensure timely documentation of deviations, CAPA, change controls, and audit findings.

Audit and Compliance Support

  • Support internal and external audits, ensuring compliance with GDP/GMP regulations.
  • Develop and track quality metrics to monitor key performance indicators (KPIs).

Risk Management and Process Improvement

  • Incorporate risk management strategies into the supply chain processes.
  • Lead initiatives to improve quality and operational efficiency using structured methodologies.

Collaboration and Communication

  • Work cross-functionally to align quality objectives and implement best practices.
  • Participate in training sessions to promote a culture of quality excellence.

Qualifications

Basic Qualifications:

  • Master’s degree + 1–3 years of experience in science/engineering, OR
  • Bachelor’s degree + 3–5 years of experience in science/engineering, OR
  • Diploma + 7–9 years of experience in science/engineering.
  • Familiarity with GMP/GDP requirements and logistics processes, including transport and warehousing.
  • Experience with QMTS processes in global markets.
  • Strong technical writing and documentation skills.

Preferred Qualifications:

  • Experience in continuous improvement and lean practices.
  • Comprehensive understanding of end-to-end supply chain processes.
  • Expertise in project management across global teams.
  • Strong analytical, problem-solving, and change management skills.
  • Proficiency with Microsoft Office tools, including Excel, Word, and PowerPoint.
  • Ability to multitask, prioritize, and work effectively under pressure.

Why Join Amgen?

What We Offer:

  • Competitive salary and comprehensive Total Rewards Plans.
  • Opportunities for professional growth in a dynamic and inclusive environment.

Impactful Work:

  • Be part of a team driving innovations that improve patient outcomes globally.

Equal Opportunity Statement

Amgen is an Equal Opportunity Employer that values diversity and inclusion. We provide reasonable accommodations for individuals with disabilities throughout the hiring process and employment lifecycle.


Ready to Transform Lives?

Apply now and be part of a team reshaping healthcare for the future.

Visit careers.amgen.com


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