Summary

About the role:

Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

About The Role

Key Requirements:

• Deliver Quality Operations and Quality Compliance activities in line with GxP, regulatory requirements, internal quality standards and SOPs.
• Manage and support quality documentation, including SOPs, working procedures, process maps, trend reports, qualification reports and technical investigations.
• Support deviations, quality events, investigations and CAPA management, including tracking, trending and timely closure.
• Support internal/external audits, inspections, self-inspections and supplier audit activities.
• Manage quality-related activities across APQR, QAA, QRA, KQI metrics and Approved Supplier Lists.
• Support vendor/supplier quality management, including supplier onboarding, assessments, agreements and monitoring.
• Generate and analyze quality metrics and reports using approved systems/tools and ensure accurate, timely deliverables.




• Maintain quality records, trackers, SharePoint content and relevant documentation.
• Partner effectively with internal stakeholders, customers and business partners while supporting continuous process improvement.

Essential Requirements

• Valuable understanding of GxP, Quality Operations and Quality Compliance requirements.
• Experience 5-7 years.
• Hands-on experience with deviations/quality events, investigations and CAPA.
• Experience creating/reviewing SOPs and other GxP/quality documentation.
• Experience supporting audits, inspections and compliance activities.
• Ability to work with quality systems/tools, generate reports and track quality metrics.
• Strong attention to accuracy, compliance, ownership and timely delivery.
• Ability to effectively communicate and collaborate with cross-functional stakeholders and business partners.

Desirable Requirements

• Experience with APQR, QAA

📌 Specialist, Quality Operations (India)
🏢 Novartis India
📍 India