Specialist, Quality Operations

Overview

Manages quality aspects and projects within the area of responsibility, ensuring and supporting overall GxP conformity and compliance with the Novartis Quality Management Systems.

What you'll do

• 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.

What you'll need

• Good understanding of GxP, Quality Operations and Quality Compliance requirements.
• Experience of 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.

Nice to have

• Experience with APQR, QAA, QRA, KQI reporting and Self-Inspection planning.
• Exposure to supplier/vendor quality management, supplier audits and Approved Supplier Lists.
• Experience with 1QEM / Quality Event Management and Quality Analytics tools.
• Exposure to GMP external audits, Health Authority inspections and supply-chain quality.
• Experience managing SharePoint, quality repositories, trackers and document archival.
• Exposure to Quality Management Review metrics/reporting and continuous improvement initiatives.

Details

• Location: Hyderabad (Office).