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Quality Lead Novartis Gbl Service Center

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Lead the development and implementation of the quality strategy and compliance standards, quality governance and quality processes applicable for all regulated GxP activities in a Novartis Global Service Center (NGSC).Lead the effective implementation of all quality requirements across the NGSC to ensure that systems and business processes are compliant with Novartis Quality and regulatory requirements. Drive implementation and reporting of adequate quality governance and respective metrics to create transparency for the overall quality and compliance status of the NGSC activities. Identify and drive implementation of sound risk-based approaches and continuous improvement opportunities.1. Lead the definition and implementation of all GxP quality standards and systems as well as governance processes for NGSC activities. Drive the development, implementation and standardization of quality requirements for new services and associated processes and systems across the NGSC. This comprises all GxP regulated activities of Product Lifecycle Services (PLS), IT, Procurement, Real Estate and Facility Services (REFS) in the respective NGSC. 2.Drive the implementation of quality plan objectives for the NGSC; ensure implementation and tracking of metrics to monitor adherence to the plan. 3.Lead the implementation of an effective quality culture in the NGSC by providing quality management oversight.4.Drive the development and implementation of transparent and effective compliance processes to facilitate the preparation, conduct and follow-up of Health Authority inspections in the NGSC. 5. Provide effective quality oversight for all activities managed by external service providers including initial qualification and on-going monitoring.6. Provide quality leadership and guidance during the development and execution of corrective and preventive actions (CAPA) in the NGSC. Ensure all CAPA are man- aged effectively and tracked to closure, assessing effectiveness as required.7. Ensure that NGSC personnel successfully implement and timely close out all internal and external commitments.8. Ensure timely and effective communication of any potential compliance gaps/risks to senior NGSC and NBS Quality management; lead resolution of gaps/risks.9.Ensure that training for NGSC personnel is effectively delivered and training compliance monitored.10. Identify and drive implementation of sound risk-based approaches and continuous improvement opportunities for NGSC systems and processes.11. Lead audit and inspection readiness on an ongoing basis and in close collaboration with relevant NBS domains.12. Drive the development and implementation of external compliance intelligence processes ensuring that new compliance and GxP requirements are proactively identified and processes continuously improved to reflect the latest Health Authority requirements and expectations. Support the identification of state of the art benchmarks through well-established industry contacts.13. Ensure effective partnership with NGSC Senior Management, Group Quality and Customer Quality groups, business functions and other business partners, as required.
Degree: M.Pharm. (Pharmacy) | MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 10-15


Bio-Statistician | Clinical Research | Data Management/ Statistics | Quality Assurance/ Control
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