Job Description Summary
The Specialist - Quality Operations supports in batch release preparatory activity, QMS activity and Regulatory compliance check.

Job Description
Major accountabilities:
- Perform Quality Operations activities supporting product quality, batch release, and regulatory compliance processes.
- Execute batch release preparatory activities, technical release verification, and regulatory compliance checks according to defined procedures.
- Ensure compliance with GxP requirements, Novartis quality standards, regulatory requirements, and internal operating procedures.
- Create, review, and maintain GxP documentation, including SOPs, working procedures, trend reports, investigations, and qualification reports.
- Support Quality Management System (QMS) activities, including deviation management, quality events, and compliance follow-up actions.
- Generate, analyze, and interpret reports from approved systems to drive operational monitoring and informed decision-making.
- Support master data management, BOM approval activities, Certificate of Analysis (CoA) generation,



and other quality-related processes.
- Escalate and support the investigation of GxP and non-GxP issues, ensuring timely resolution and compliance.
- Provide support during internal and external audits through data collection, reporting, and presentation of quality documentation.
- Deliver accurate and timely results while supporting KPI reporting, digital/data-driven initiatives, and additional business or departmental requirements.

Essential requirements:
- Bachelor's or Master's Degree in Pharma or equivalent.
- 5-7 years of experience within a GMP Quality Assurance department with a focus on batch release activities.
- Experience with QMS processes, particularly deviations, quality events and compliance activities.
- Exposure to regulatory compliance or regulatory affairs activities.
- Explicit and effective communication in English.

Commitment to Diversity and Inclusion
Novartis is c

📌 Specialist - Quality Operations (Hyderabad)
🏢 Novartis
📍 Hyderabad