Quality Operations Jobs – Novartis is hiring a Specialist/Analyst – Quality Operations in Hyderabad, India (Job ID: REQ-10074566).
This full-time role is ideal for candidates with a minimum of 3 years of experience in Quality Assurance, Regulatory, or pharmaceutical manufacturing who are passionate about ensuring product quality compliance, supporting QC release activities, and maintaining high standards in a global pharmaceutical environment.
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About the Company
Novartis is a leading global medicines company headquartered in Basel, Switzerland, with a mission to reimagine medicine and improve patient lives through innovative therapies in oncology, immunology, neuroscience, and other therapeutic areas.
With a strong presence in India, including operations in Hyderabad, Novartis maintains rigorous quality standards, regulatory excellence, and a commitment to continuous improvement.
The company fosters an inclusive, collaborative culture that values integrity, innovation, and professional development, offering meaningful opportunities in quality operations and regulatory compliance.
Job Details
- Company Name: Novartis
- Position: Specialist/Analyst – Quality Operations
- Experience: Minimum 3 years in Quality Assurance, Regulatory, or pharmaceutical manufacturing of drug substances/products/medical devices
- Qualification: Pharmacy / Science / MBA / Engineering / equivalent from a reputed institute
- Location: Hyderabad (Office), Telangana, India
- Work Type: Full-time
- Application Deadline: April 30, 2026
Job Description
The Specialist/Analyst – Quality Operations will provide quality services in compliance with cGMP requirements and the Novartis Quality Management System.
The role supports manufacturing sites with QC release activities, testing monograph management, nitrosamine risk evaluations, statistical support, performance trending, and business support while ensuring regulatory compliance and audit readiness.
Specialist/Analyst – Quality Operations
- Department: Quality Operations
- Market: Pharmaceuticals – Global Quality & Compliance
- Role: Specialist/Analyst
- Experience: Minimum 3 years
- Education/Qualification: Pharmacy / Science / MBA / Engineering / equivalent
Skills/Qualifications
- Minimum 3 years of experience in Quality Assurance, Regulatory, or pharmaceutical manufacturing
- Strong knowledge of GxP, cGMP, and quality management systems
- Proficiency in creating/modifying inspection plans, certificates of analysis, specifications, and testing monographs
- Experience in authoring nitrosamine risk evaluation reports (Step 1 & Step 2) and using Subway software
- Ability to perform statistical support, performance trending, and business analysis
- Good communication, presentation, and interpersonal skills
- Experience working with global stakeholders and in multicultural environments
Key Responsibilities
- Perform and deliver Quality Operations services to support product quality compliance and regulatory workflows
- Support QC release activities: create/modify/review inspection plans, inspection lot numbers, certificates of analysis, specifications, etc.
- Support testing monograph management: author monographs, perform impact assessments
- Author nitrosamine risk evaluation reports (Step 1 & Step 2), handle country-specific reports, and prepare slides for workstream/Steerco meetings
- Provide statistical support, performance trending, and business support
- Ensure compliance with Novartis internal quality standards, regulatory requirements, and service level agreements
- Comply with internal procedures (time tracking, KPI reporting, ticket management)
- Support internal and external audits
- Adhere to current GxP and compliance policies of Novartis
Benefits/Perks
- Career growth in a global pharmaceutical leader with strong quality focus
- Exposure to regulatory workflows, nitrosamine assessments, and QC release activities
- Opportunities for skill development in data analytics, compliance, and global stakeholder management
- Inclusive, collaborative work culture with emphasis on innovation and patient impact
- Competitive compensation and comprehensive benefits package
How to Apply
Apply directly through the Novartis careers portal: https://www.novartis.com/careers (search for Job ID REQ-10074566 or “Specialist/Analyst – Quality Operations Hyderabad”).
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Novartis Career page.
Submit your updated resume highlighting 3+ years of relevant experience in Quality Assurance or manufacturing. For more quality operations jobs, QA/QC roles, regulatory affairs openings, and pharma careers in Hyderabad, visit Pharma Recruiter.
Apply before April 30, 2026, and contribute to Novartis’ commitment to quality and patient safety!
Why You Should Join
Novartis offers a prestigious platform for quality professionals to work in a global, compliance-driven environment with exposure to advanced QC release processes, nitrosamine risk assessments, and cross-functional collaboration.
With a strong focus on innovation, regulatory excellence, and employee development, the company provides meaningful work, career progression, and the opportunity to impact global healthcare while building expertise in a values-driven organization.
FAQs
What is the minimum experience required for the Specialist/Analyst – Quality Operations role?
Minimum 3 years in Quality Assurance, Regulatory, or pharmaceutical manufacturing of drug substances/products/medical devices.
Is GxP knowledge mandatory?
Yes—strong GxP knowledge and basic IT skills are required.
Where is the job located?
Hyderabad (Office), Telangana, India.
What growth opportunities exist in this role?
Strong potential for advancement in global quality operations with exposure to regulatory workflows, data analytics, and cross-functional stakeholder management in a leading pharmaceutical company.
