Band
Level 3

Job Description Summary
LI-Hybrid

Location: Hyderabad, India

This role is based in Hyderabad, India. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

The Specialist, Quality Operations manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

Job Description
Major Accountabilities:
Manage Change Controls from initiation through closure using approved Novartis systems.
Ensure timely, accurate, and compliant execution of assigned activities.
Support KPI reporting, governance activities, and business process requirements.
Create and review GxP documents, SOPs, trend reports, qualification reports, and investigations as required
Support internal and external audits by providing process documentation, data, and reports.
Escalate GxP and non-GxP issues and support investigation activities.




Generate and analyze reports and follow up on actions arising from quality processes.
Perform designated roles such as CRB Facilitator, Entity Data Manager, Business Approver as per business needs,
Maintain compliance with Novartis quality standards, regulatory requirements, and operating procedures.

Required Competencies
Master’s degree in Science, Engineering, or an equivalent qualification
Minimum of 6 years’ experience in Quality Assurance, Regulatory Affairs, Pharmaceutical Manufacturing, or Medical Devices
Stakeholder management and Project coordination
Knowledge of change control and quality systems
Data analysis and reporting capabilities
Proficiency in enterprise digital tools and MS Office applications
Basic understanding of GxP requirements

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With

📌 Specialist, Quality Operations Hyderabad
🏢 Novartis
📍 Hyderabad