Product Quality Specialist
📍 Location: India – Hyderabad (On-site)
🆔 Job ID: R-224578
📅 Date Posted: September 2, 2025
📂 Category: Quality
About Amgen
At Amgen, we believe in serving something bigger than ourselves—our mission is to help patients living with serious illnesses. Since 1980, we’ve pioneered biotechnology to fight the toughest diseases, with a focus on Oncology, Inflammation, General Medicine, and Rare Diseases, reaching millions of patients each year.
Our culture is collaborative, science-driven, and innovative. If you’re passionate about challenges and opportunities that make a real impact, you’ll thrive here. Join us and transform both patients’ lives and your career.
Role Overview
As a Product Quality Specialist, you will provide technical expertise and product leadership within the Product Quality (PQ) organization. This role supports one or more late-stage and/or commercial biologics or synthetic programs. You will work cross-functionally with Product Quality Leaders (PQLs), International Distribution Quality, Regulatory, Process Development, Quality Assurance, and Quality Control teams.
Your responsibilities will include authoring/reviewing GMP and regulatory documents, managing product data, supporting product specifications, stability assessments, periodic reviews, complaint resolution, and contributing to overall product health.
Key Responsibilities
Support PQ activities for late-stage and/or commercial biologic or synthetic programs (e.g., PQT, APR, specifications, comparability, stability programs, regulatory filings).
Author and review GMP and regulatory documents (protocols, specifications, assessments, RTQ responses).
Manage product quality data including stability, comparability, complaints, and method performance.
Conduct science- and risk-based evaluations of process/product quality data.
Execute transactions in GMP systems (document management, complaint resolution, and data systems).
Ensure compliance with cGMP and international regulatory expectations.
Support Product Quality initiatives to ensure overall product health and lifecycle management.
Qualifications
Basic Qualifications
Master’s degree in Chemistry, Biochemistry, Biology, or related Pharmaceutical Sciences.
8–13 years of experience in Quality, Operations, Scientific, or Manufacturing roles.
Preferred Qualifications
Must-Have Skills
Proficiency in Biologics manufacturing processes and analytical methods.
Experience with comparability protocols, product specifications, stability assessments.
Strong understanding of cGMP and international regulatory guidelines.
Excellent oral and written communication skills for complex technical content.
Strong data management and organizational skills with attention to detail.
Ability to meet project timelines using GMP Quality systems.
Collaboration and relationship-building skills across multi-functional teams.
Good-to-Have Skills
Experience working in global, virtual, matrix teams across time zones.
Exposure to combination products (e.g., pre-filled syringes, pen injectors).
Familiarity with tools such as Veeva, Spotfire, SHINY, and proficiency in MS Office Suite.
Soft Skills
Analytical and problem-solving mindset.
Ability to manage multiple priorities and work under pressure.
Strong initiative, self-motivation, and adaptability.
Team-oriented with strong presentation and public speaking skills.
What We Offer
Competitive base salary and Total Rewards Plan aligned with industry standards.
Opportunities for career growth and professional development.
Collaborative and inclusive culture where your work truly makes an impact.
Commitment to diversity, equity, inclusion, and belonging (DEI&B).
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. We welcome all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.
Reasonable accommodations will be provided for individuals with disabilities in the application and hiring process.
👉 Apply Now at careers.amgen.com
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