CAREER CATEGORY

Quality

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
* Solid organization skills with high attention to detail
* Ability to meet deadlines and de

📌 Associate Product Quality (Hyderabad)
🏢 AMGEN
📍 Hyderabad