Associate Product Quality - Data Verification

Amgen Inc. (IR); Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amgen is seeking an Associate Quality Compliance in Hyderabad to support Product Quality Teams. The role verifies data accuracy, regulatory readiness, and GMP compliance across late-stage and commercial products in a global, fast-paced environment.

You will navigate GMP systems (Veeva, LIMS, Spotfire) and review technical documents, ensuring timely, high‑quality deliverables with strict data integrity and cross-functional collaboration.

Qualifications

• Bachelor's or Master's degree with 3+ years in pharma or related field.
• Experience supporting GMP/compliance is preferred.
• Familiarity with GMP systems and regulatory documentation.

Responsibilities

• Execute data reviews in GMP systems and verify accuracy of technical documents.
• Navigate GMP systems across global teams to identify data sources and ensure regulatory readiness.
• Collaborate with authors across sites to maintain compliance and timely project milestones.
• Provide guidance to document authors to ensure quality and accuracy.

Skills

GMP knowledge

Data verification

Regulatory readiness

Organization skills

Communication skills

Education

Bachelor's/Master’s in Pharmaceutical Sciences

Tools

Veeva

LIMS

Spotfire

SampleManager LIMS

MS Office

Job description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description: The Associate Quality Compliance is an individual contributor role that plays a vital part in supporting Product Quality Teams (PQTs). This role ensures adherence to Amgen’s compliance practices for late-stage and commercial products by reviewing critical data and documents to confirm accuracy, integrity, and regulatory readiness. Through diligent verification, navigation of GMP‑compliant systems, and close collaboration across global teams, you will help ensure Amgen continues to deliver products of the highest quality and safety.

Roles & Responsibilities

• Execute transactions in GMP computer-based systems (e.g., Veeva, LIMS).
• Review and verify data in technical documents within GMP Quality systems.
• Navigate GMP systems (Spotfire, Veeva, SampleManager LIMS) to identify and validate data sources.
• Manage time-sensitive compliance activities across multiple teams and projects independently.
• Collaborate with document authors across sites and time zones to support project milestones.
• Provide guidance and feedback to authors of GMP documents to ensure compliance and accuracy.

Basic Qualifications and Experience

Bachelor's/Master’s degree with minimum of 3 years of pharmaceutical industry or directly related experience

Functional Skills

Must-Have Skills

• General knowledge of GMP principles and pharmaceutical industry standards for Quality
• Strong organization skills with high attention to detail
• Ability to meet deadlines and deliver high-quality results using GMP systems
• Excellent written and verbal communication skills

Good-to-Have Skills

• Knowledge of FDA and ICH regulations
• Experience working in cross-functional, virtual teams across time zones
• Familiarity with GMP applications such as Veeva, Spotfire, SampleManager LIMS
• Proficiency in MS Office (Word, Excel, PowerPoint, Teams)

Soft Skills

• Strong initiative and self-motivation
• Team-oriented mindset with focus on achieving shared goals
• Ability to work effectively in diverse, global, virtual environments

What Success Looks Like

• Timely and accurate completion of document reviews and compliance activities
• Proactive collaboration with cross-functional teams to meet project timelines
• Effective use of GMP systems to maintain compliance and data integrity

Growth & Development

Amgen invests in employee growth. In this role, you will receive structured training on GMP systems and mentoring to develop your compliance expertise.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer. We will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We are committed to providing reasonable accommodation for individuals with disabilities during the application and interview process, in performing essential job functions, and in accessing employment benefits. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen