Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Specialist - Quality Operations
Summary
The Specialist - Quality Operations supports in batch release preparatory activity, QMS activity and Regulatory compliance check.
Job Description
• 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.
Candidate Profile
• 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.
• Clear and effective communication in English.
Additional Information
Experience : 5-7 Years
Qualification : MPharma / BPharma
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID REQ : REQ-10086080
End Date : 30th September 2026
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