Here’s a concise and well-organized rewrite of the job summary for clarity and engagement:
Quality Operations Specialist
Location: Hyderabad, India
About Novartis:
At Novartis, we strive to improve lives through innovative science, collaboration, and a commitment to quality. Join our team and help create a brighter future for patients worldwide.
About the Role:
As a Quality Operations Specialist, you will deliver quality services that ensure compliance with cGMP standards and the Novartis Quality Management System. Your role will support key quality activities across product compliance, regulatory workflows, and operational excellence.
Key Responsibilities:
Provide quality operations services for product compliance, including workflows in applications like SAP, Dragon, and SUBWAY.
Support stability management tasks such as temperature excursion assessments (TEA) and transport risk assessments (TRA).
Assist QC release activities, including creating and reviewing Inspection Plans, Lot Numbers, Certificates of Analysis, and Compliance.
Develop and manage testing monographs and perform impact assessments.
Author risk evaluation reports for nitrosamines (Step-1 & Step-2) and manage associated activities in Subway software.
Perform statistical analysis, performance trending, and provide business support.
Ensure compliance with Novartis quality standards, regulatory requirements, and service level agreements.
Support internal and external audits while adhering to GxP and compliance policies.
Key Performance Indicators:
On-time and GMP-compliant release of products.
Effective handling of inspections with no adverse findings.
Successful participation in continuous improvement initiatives.
Minimum Requirements:
Education: Pharmacy, Science, MBA, Engineering, or equivalent from a recognized institute.
Experience: Minimum 3 years in Quality Assurance, Regulatory, or pharmaceutical manufacturing.
Skills: GxP knowledge, basic IT expertise, excellent communication and interpersonal skills, experience working with global stakeholders.
Languages: Fluent in English (written and spoken).
Desirable Skills:
Continuous learning mindset.
Knowledge of GMP procedures and QA/QC testing.
Technological expertise and adaptability.
Why Novartis:
We believe improving lives requires more than science—it takes a passionate community working together to inspire breakthroughs. Be part of a team that values inclusion, diversity, and innovation.
Accessibility and Accommodation:
Novartis is committed to providing reasonable accommodations for individuals with disabilities. For support, email diversityandincl.india@novartis.com, including the job requisition number.
Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full-Time, Regular
Join the Novartis Talent Network to explore opportunities and grow your career with us.
Let me know if you’d like further adjustments!
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