Associate Quality

Amgen; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

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Job summary

Amgen is seeking an Associate Quality Compliance professional in Hyderabad to support product quality teams by verifying data and ensuring regulatory readiness.

The role requires collaboration with global teams, review of GMP documents, and use of GMP systems to maintain data integrity and compliance across late-stage and commercial products.

Qualifications

• Minimum 3 years of pharmaceutical industry or related experience.
• Experience reviewing data and documents for GMP compliance.
• Understanding of GMP principles and quality systems.

Responsibilities

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

Skills

GMP principles

Organizational skills

Time management

Written & verbal communication

Education

Bachelor’s/Master’s degree

Tools

Veeva

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.