Sr Quality Engineer

Amgen Technology Private Limited

Hyderabad

3-13 Years

This job is no longer accepting applications

Posted 2 months ago
Over 100 applicants

Job Description

Key Deliverables:

Provide quality oversight across design, validation, and lifecycle of combination products
Support regulatory submissions, audits, and RTQ responses
Ensure compliance with global standards including ISO 13485 and 21 CFR
Lead quality process improvements for device, labeling, and packaging

Role Responsibilities:

Act as single point of quality contact for final product activities
Review risk management, HFE documentation, and design controls
Train teams on quality and regulatory requirements for combination products
Manage complaint investigations and site transfer quality activities

More Info

Job Type:

Permanent Job

Industry:

Pharmaceutical

Role:

Bio-Technology Research Scientist, Product Manager, Quality Assurance - Manager, Quality Control Manager

Function:

Pharmaceutical/Biotechnology

Employment Type:

Full time

Open to candidates from:

Indian

About Company

Amgen Technology Private Limited

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. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average, and we are also part of the Nasdaq-100 Index, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

Job ID: 119663119

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