Executive - QMS CoE Mumbai 4
Novartis
Mumbai, India
2d ago

Job Description

Why consider Novartis?

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.

Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Responsible for the coordination of the QMS CoE activities for GxP functions assuring that the process adheres to the QM directives, Global and Local SOPs, Health Authorities requirements.

Support the actions that enable the QMS CoE implementation and growth in terms of the number of users and services provided.

Build a strong collaboration with NCQ sites to ensure customer service, compliance and efficiencies. Support the continuous improvement to drive process Excellence.

1. Coordinate operation of QMS Center of Excellence like Deviations, Quality Events, CAPA, Supplier / Vendor Management, Audits, APQR’s etc.

ensuring an excellence standard in the service provided to the countries, as well as full compliance of Global regulatory requirements and Novartis standards 2.

Co-create and implement processes from QMS CoE in collaboration with Global Quality process owners, according to global requirements from the countries and business needs.

3. Provide business process collaboration with the users to ensure expected service level as well as the continuous improvement of the QMS CoE.

4. Facilitate the change management and onboarding of the new users to QMS CoE services to ensure a smooth process delivery and avoid not fulfilling any regulatory requirement or a business disruption.

5. A subject matter expert and point of contact for the users for troubleshooting and service needs. 6. Monitor and drive performance of the QMS CoE to ensure KPI’s and efficiencies expected by Global and the countries according to business needs, NCQ standards and global regulatory requirements.

7. Collaboration with QMS CoE Lead in the growth of the QMS CoE by bringing additional volumes and processes according to global NCQ strategy.

8. Collaborate with Global OpEx business process owners in the reengineering and implementation of tools to drive efficiencies within the QMS CoE.

9. Develop and establish the systems and procedures to ensure the efficient and compliant operation of the QMS CoE according to Novartis policies and in compliance with global HA expectations and regulations.

High customer satisfaction / responsiveness (no customer complaint) Ensure KPI’s according to Global targets and Global HA’s expectations Generation / delivery of reports related to the administration of QMS activities, reporting as per established QA requirements Ensure implementation timelines of Global projects for the CoE No critical observations from internal audits or Health Authority Inspections.

Minimum requirements

Degree in Sciences / Pharmacy

Communication : English fluent written and spoken

Experience : 4 -5 years at least in roles with Pharmaceutical GxP background (Quality, Production, Development)

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