Specialist, Quality Operations

Specialist, Quality Operations

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 our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Skills Desired

Collaboration, Communication, Data Integrity, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)

Experience Level

Mid Level