REQ-10028734
Nov 05, 2024
India

Summary

-Ensure compliance and further development, support, maintenance and constant review of the Quality Systems and support for projects as well as the reporting of the necessary performance indicators (KPIs) & quality indicators (KQIs). Support implementation of effective & efficient processes that fulfill regulatory requirements & expectations in a sustainable way for the global Novartis portfolio of products.

About the Role

Major accountabilities:
  • Ensure that the Quality System is compliant with the global guidelines and that all relevant regulations and legal requirements are adhered to set up a quality system with GxP and monitor the periodic inspection and updating quality-relevant processes -Continually improve and harmonize the quality-relevant processes, strengthen the awareness of quality, technical service, quality-relevant product tests, eliminate barriers relevant to the process and anticipate quality problems.
  • Support the departments in case of Quality assurance questions -Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatorycompliance risks -Performs self-assessments -Support a compliance and quality culture -Provides expert advice and input and harmonize and continuous optimize processes within QA area -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:
  • Achieve agreed targets in terms of quality, time & cost throughsuccessful project teamwork resulting in greater customer satisfaction -Exemplify Novartis Values & Behaviors and other professionalcompetencies in support of the assigned unit and the provision ofappropriate services.
Minimum Requirements:
Work Experience:
  • Functional Breadth.
  • Fix-its/Turnarounds.
  • Project Management.
Skills:
  • Compliance Requirements.
  • Continuous Learning.
  • Dealing With Ambiguity.
  • Decision Making Skills.
  • Gxp.
  • Industry Standards.
  • Project Management.
  • Quality Management Systems (Qms).
  • Quality Standards.
  • Risk Management.
  • Self Awareness.
  • Technological Expertise.
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

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Operations
Innovative Medicines
India
Hyderabad (Office)
Quality
Full time
Regular
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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REQ-10028734

Global QMS Manager

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