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 cutting-edge 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:

This role is an individual contributor role that provides critical support to
Product Quality Teams (PQTs) for late-stage clinical and commercial products. In
this role, you will serve as a primary author of technical and regulatory
reports, manage GMP data within compliant systems, and help ensure accuracy,
completeness, and compliance across global submissions.

You will also play an integral role in maintaining Amgen’s electronic databases
and mapping tools, supporting continuous improvement initiatives, and providing
peer training as needed.



This role requires strong expertise in GMP compliance,
technical writing, and cross-functional collaboration to drive high-quality
outcomes under tight timelines.

Roles & Responsibilities:

* Navigate and execute transactions in GMP systems (Empower, LIMS, Veeva,
Spotfire).
* Work closely with in the product Quality organization to drive
standardization of data, and chromatographic overlay activities.
* Author and maintain GMP technical reports supporting regulatory filings
within quality systems (e.g., Veeva).
* Collate, review, verify, and archive GMP data for late-stage clinical and
commercial products.
* Ensure accuracy and completeness of product data with high attention to
detail.
* Collaborate across global teams and time zones, effectively communicating
findings and project updates.

Basic Qualifications

* Master’s degree with minimum 6 years of Pharmaceutical/Biotechnology
experience in Quality, Op

📌 Sr Associate Product Quality (Hyderabad)
🏢 AMGEN
📍 Hyderabad