Sammanfattning
• 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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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.
