Senior Associate QA, Global Distribution Quality
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Feb. 04, 2025
Category: Quality
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Associate QA, Global Distribution Quality
What You Will Do:
We are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team. This is an exciting opportunity to join a team of quality professionals in global distribution operations.
Role Description:
The Sr. Associate QA position will oversee global product distribution and transportation from Amgen’s Global Supply Hubs to global markets, providing QA oversight of Global Supply Chain operations. This role may require working shifts or extended hours within the same shift.
Key Responsibilities:
Serve as QA Contact for Quality Events, Change Control records, CAPAs, effectiveness verification, and QA triage of Distribution complaints.
Ensure end-to-end compliance with GMP/GDP in coordination with relevant collaborators.
Act as SME for transportation-related Quality Processes.
Prepare, review, and approve SOPs and other GMP/GDP documentation to ensure compliance with corporate and regulatory standards.
Collaborate with third parties to ensure adherence to service levels, identifying and implementing performance improvements.
Support logistic and transportation service provider oversight.
Provide support for internal/external audits and inspections.
Offer quality expertise and guidance to operational staff and cross-functional Amgen teams.
Engage in operational improvement initiatives, programs, and projects.
Maintain supplier metrics, performance assessments, and key documents.
Work independently with minimal supervision in alignment with Amgen Values and Leadership Attributes.
What We Expect of You:
Basic Qualifications:
Bachelor’s degree in science or engineering and 2+ years of professional experience in related fields.
Understanding of GMP/GDP requirements.
Familiarity with logistics processes including parcel, transport, and warehousing providers.
Experience in Validation/Qualification of processes, equipment, and facilities.
Strong technical writing skills.
Preferred Qualifications:
Strong continuous improvement attitude and lean practices experience.
Understanding of end-to-end supply chain business processes.
Experience in project management across multiple departments and geographies.
Quick process understanding, insight, and visualization.
Strong analytical and problem-solving skills.
Independent self-starter, able to work autonomously, under pressure, and in teams.
GMP/GDP knowledge and understanding of pharmaceutical regulations.
Energetic, detail-oriented, highly motivated with a “can do” outlook.
Change management skills.
Excellent communication skills across all levels of the organization.
Experience with Microsoft Office tools including Excel, Word, and PowerPoint.
Ability to multi-task and prioritize effectively.
What You Can Expect of Us:
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply Now
for a career that defies imagination.
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