Specialist – Quality Operations | Novartis India
Location: Hyderabad, Telangana
Work Type: Full-time
Estimated Salary: ₹5.5–8 LPA (based on experience and market benchmarks)
About the Role:
Novartis is hiring a Specialist in Quality Operations to provide high-standard quality services in compliance with cGMP requirements and the Novartis Quality Management System (QMS). This role supports regulatory workflows and product quality compliance while working closely with both internal teams and external manufacturing partners.
Key Responsibilities:
General Quality Operations:
Deliver quality services aligned with GxP, cGMP, and Novartis QMS.
Operate tools like SAP, Dragon, SUBWAY, AGILE PLM, AQWA, etc.
Generate and analyze predefined and ad-hoc reports and ensure follow-up actions.
Escalate GxP and non-GxP issues and support in timely investigations.
Comply with internal SOPs, KPIs, time tracking, ticket management, and training requirements.
Support internal/external audits and inspections by providing relevant process documentation.
Ensure timely and accurate execution of assigned tasks and data reporting.
Annual Product Quality Review (APQR):
Extract data from various Novartis systems for APQR compilation.
Draft product quality evaluations and conclusions using standardized templates.
Coordinate with CMOs/manufacturing sites and update APQR schedules.
Review and archive APQR reports, ensuring accuracy and completeness.
Update and interpret APQR data in e-compass.
Marketing Authorization Holder (MAH) Review:
Maintain and coordinate MAH/BRS review schedules.
Compile data into MAH/BRS templates from relevant internal/external sources.
Review documentation for completeness and accuracy.
Submit compiled reviews for approval and archive approved documents accordingly.
Key Performance Indicators (KPIs):
Timely completion of APQRs and MAH/BRS reviews.
Compliance with documentation standards and internal SOPs.
Effective use of Novartis systems and tools.
Accuracy and completeness of quality data reporting.
Qualifications & Experience:
Education: M.Pharm, MBA, B.Tech, M.Tech, or equivalent in a science/engineering discipline.
Experience: Minimum 1 year in Quality Assurance, Regulatory Affairs, or pharma manufacturing/medical devices.
Knowledge: Basic understanding of GxP and regulatory compliance.
Why Join Novartis?
Work in a purpose-driven environment aiming to reimagine medicine.
Contribute to a company recognized for innovation, diversity, and inclusion.
Access world-class benefits, learning tools, and career progression opportunities.
Collaborate in a global team dedicated to patient safety and product quality.
Explore more about our work culture and employee benefits:
Novartis Life Handbook
Accommodation for Disabilities:
Email: diversityandincl.india@novartis.com
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