eCompliance Intern

Summary

-• Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure.
• Collaborate with the IT team to provide QA oversight for all the IT projects, ensuring regulatory compliance.
• Conduct thorough review of all the system development lifecycle documents to ensure assurance before the IT solutions are getting deployed in Production.
• Curious in learning various global Regulatory requirements relating to Computerized systems and curious in learning the emerging technologies to provide proactive compliance guidance to the IT colleagues.
• Collaborate with cross-functional teams to ensure Inspection readiness for all the GxP IT systems throughout their lifetime.

• Support the life-cycle of GxP computerized systems with periodic re-evaluation of the validation status, change controls, deviations management ensuring that relevant documentation is in place and maintained according to the Novartis requirements.
• Provide the needed e-Compliance support for the Strategic IT Projects
• Support the measurement of Key Quality Indicators (KQI) and execution of Data Integrity (DI) Plan.

About the Role

Major accountabilities:

• Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure.
• Collaborate with the IT team to provide QA oversight for all the IT projects, ensuring regulatory compliance.
• Conduct thorough review of all the system development lifecycle documents to ensure assurance before the IT solutions are getting deployed in Production.
• Curious in learning various global Regulatory requirements relating to Computerized systems and curious in learning the emerging technologies to provide proactive compliance guidance to the IT colleagues.
• Collaborate with cross-functional teams to ensure Inspection readiness for all the GxP IT systems throughout their lifetime.
• Support the life-cycle of GxP computerized systems with periodic re-evaluation of the validation status, change controls, deviations management ensuring that relevant documentation is in place and maintained according to the Novartis requirements.
• Provide the needed e-Compliance support for the Strategic IT Projects
• Support the measurement of Key Quality Indicators (KQI) and execution of Data Integrity (DI) Plan.

Key performance indicators:

• Customer satisfaction, punctuality rate -Jobs done on time, following the specified cycle time -Consistent compliance with GxP and Health, Safety and Environment guidelines and Standard Operating Procedures -No complaints with regulatory inspections

Minimum Requirements:
Work Experience:

• Functional Breadth.

Skills:

• Compliance Requirements.
• Continuous Learning.
• Dealing With Ambiguity.
• Gxp.
• Industry Standards.
• Quality Standards.
• Self Awareness.
• Technological Expertise.

Languages :

• English.

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Division
Operations

Business Unit
Innovative Medicines

Location
India

Site
Hyderabad (Office)

Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area
Quality

Job Type
Full time

Employment Type
Regular

Shift Work
No