Specialist - Quality Operations
Novartis
2 - 5 years
Hyderabad
Posted: 21/05/2025
Job Description
Summary
About the Role
Major accountabilities:
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration
Minimum Requirements:
Work Experience:
- Functional Breadth.
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- Collaborating across boundaries.
- cleanliness zones.
Skills:
QMS
BMR/ BPR review
Batch Release process
Quality Management
Regulatory compliance checks
Languages :
- English.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
About Company
Novartis is a leading global healthcare company headquartered in Basel, Switzerland. It specializes in the research, development, manufacturing, and marketing of innovative pharmaceuticals. Formed in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis focuses on areas such as oncology, neuroscience, immunology, cardiovascular diseases, and gene therapies.With a strong commitment to scientific innovation, Novartis invests heavily in R&D and collaborates with biotech companies and academic institutions worldwide. The company operates in over 140 countries and serves millions of patients globally. Novartis is also known for its efforts in access to medicine, using programs like Novartis Access and Novartis Foundation to support underserved populations.
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