About this role
Job title: Specialist, Quality Operations
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:
- 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.
Desirable Requirements:
- 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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB)
Division Operations
Business Unit Other
Location
India
Site Hyderabad (Office)
Company / Legal Entity 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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Job ID REQ-10088961
Specialist, Quality Operations