Associate Ecompliance Specialist

2 days ago

Hyderabad Telangana, India Novartis Full time

Summary o 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 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 Skills Desired Compliance Requirements Continued Learning Dealing With Ambiguity Gxp Industry Standards Quality Standards Self-Awareness Technological Expertise

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