A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Quality Lead
Job Description:
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.
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Candidate Profile:
Degree in Life Sciences, Pharmacy or Medicine, or other relevant discipline required. Advanced degree desirable Fluency in English (oral and written); additional language(s) a plus Ten (10) plus years of experience in the pharmaceutical industry,
preferably incl. experience in clinical development and/or relevant QA/ Compliance roles
Additional Information:
Experience: 10+ Years
Location: Hyderabad
Education: Degree in Life Sciences, Pharmacy
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality
Division: Pharma
Job Type: Full Time
Employment Type: Regular
Job ID: 194606BR
End Date: 13th September, 2016
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