Specialist Quality Assurance - Global Supply Quality

6+ years

Not Disclosed

Hyderabad India

10 Feb. 17, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Specialist Quality Assurance - Global Supply Quality

LOCATION: India - Hyderabad
WORK LOCATION TYPE: On Site
DATE POSTED: Feb. 01, 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist Quality Assurance - Global Supply Quality

What you will do

Let’s do this. Let’s change the world. In this vital role, you will serve patients through internal collaboration with Amgen’s global quality teams, manufacturing sites, and external engagement with suppliers of raw materials and devices. You will make key contributions to ensure high quality and right-first-time materials are received at Amgen, build a resilient supply network, and deliver a positive patient experience.

In this role, you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of external suppliers and contract manufacturers.

Roles & Responsibilities:

Periodic review and updates to quality agreements to ensure alignment with Amgen expectations and to address needs depending on material type.
Documentation review and approval including supplier records, investigation reports, Amgen quality records, and validation records.
Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles.
Oversight and completion of supplier assessments and documentation to support product complaints.
Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.
Review and approval of change control records for supplier changes.
Management of supplier audit records, ensuring on-time completion and CAPA closeout activities are documented with appropriate closeout evidence.
Prepare, review, and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
Take part in operational and quality improvement initiatives, programs, and projects.
Develop solutions that are thorough, practical, and consistent with functional objectives.
This role may require working in shifts or extended hours within the same shift to support global time zones.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Doctorate degree OR
Master’s degree with 4+ years of experience in quality management systems or a related field OR
Bachelor’s degree with 6+ years of experience in quality management systems or a related field OR
Diploma with 8+ years of experience in quality management systems or a related field.

Preferred Qualifications:

Must-Have Skills:

Minimum of 2 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.

Good-to-Have Skills:

Experience in creating digital solutions and working within computerized systems.
Experience in investigations, project management, trending, and analysis.
Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
Understanding of the applicable manufacturing/testing processes and regulatory requirements (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes, and combination products).
Desire to partner with internal and external stakeholders across teams.
Understanding of industry requirements/expectations of a robust Quality Management System and documentation.

Soft Skills:

Excellent analytical and troubleshooting skills.
Strong verbal and written communication skills.
Ability to work effectively with global, virtual teams.
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Team-oriented, with a focus on achieving team goals.
Strong presentation and public speaking skills.

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.

Objects in your future are closer than they appear. Join us.
careers.amgen.com

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