Specialist, Quality Operations

Novartis AG; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Novartis Healthcare Private Limited in Hyderabad is seeking an experienced Quality Operations and Compliance professional to manage GxP conformity and drive continuous improvement across quality-related activities.

The role involves handling deviations, quality events, CAPA management, audits, supplier quality and metrics reporting, with heavy emphasis on documentation control and cross-functional collaboration. 5-7 years of relevant experience is expected.

Qualifications

• 5-7 years of experience in quality operations/compliance in pharma.
• Hands-on with deviations, quality events, investigations and CAPA.
• Experience supporting audits, inspections and supplier quality management.

Responsibilities

• 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 and investigations.
• Support deviations, quality events, investigations and CAPA management, including tracking and timely closure.
• Support internal/external audits, inspections and supplier audit activities.
• Generate and analyze quality metrics and reports using approved systems and ensure timely deliverables.
• Maintain quality records, trackers, SharePoint content and relevant documentation.
• Collaborate with internal stakeholders and business partners to support continuous process improvement.

Skills

Quality Operations

Quality Compliance

GxP knowledge

CAPA management

Audits & inspections

Quality metrics

SharePoint

Cross-functional collaboration

GMP audits

Documentation control

Education

Bachelor's degree in Life Sciences

Tools

SharePoint

Job description

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.
• Good 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.
• 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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area Quality

Job Type Full time

Employment Type Regular

Shift Work No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e‑mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.