Quality Operations-Specialist Novartis India

0.0 years

0 Lacs

hyderabad, telangana, india

On-site

Summary 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 Responsibilities: 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 o...

Posted 2 days ago

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Specialist, GMP QA Oversight, QOP India Sandoz

5.0 - 11.0 years

3 - 9 Lacs

hyderabad, telangana, india

On-site

Key Responsibilities: 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) Commitment to Diversity Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patient...

Posted 1 month ago

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QA Officer Operations Sandoz

3.0 - 7.0 years

6 - 13 Lacs

hyderabad, telangana, india

On-site

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 responsi...

Posted 1 month ago

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Specialist/Analyst - Supplier Quality Management Novartis

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for managing End to End Supplier Quality & Compliance Management activities, such as drafting Quality Assurance Agreements, conducting Quality Risk Assessments, preparing Annual Monitoring Reports, and overseeing New Supplier/Material Onboarding/Exit processes. As the key person in Supplier Quality Management, your duties will include drafting Annual Monitoring and Certification reports for incoming materials, negotiating and archiving Quality Assurance Agreements with Suppliers/Service providers, evaluating and managing Supplier Change Notifications, drafting Suppliers" incoming materials Specifications, performing Quality Risk Assessments for existing and new Suppli...

Posted 1 month ago

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