Novo Nordisk Hiring For Advanced Business Analyst _Regulatory Compliance & CSV at Bengaluru , Bangalore Full Time

Department – CVT CoE xDD&IT Services

Does your motivation come from challenges and working in a dynamic environment Do you thrive in an environment where close collaboration with key stakeholders and strategic alignment is essential Do you have a can-do attitude with continuous improvement as one of your career objectives Then we might have the right position for you. Apply now!

The Position

As an Advanced Business Analyst I, you will be responsible for performing various tasks related to Regulatory Compliance and Computerized System Validation (CSV) including:

• Act as a compliance consultant to IT Systems ensuring alignment to regulatory requirements and NN QMS (Quality Management System).
• Periodic Reviews of the IT Systems including user reviews and maintaining the validated state of the IT System.
• Deviation Handling – RCA (Root Cause Analysis) using 5 x Why approach or any similar approach and CAPA (Corrective and Preventive Actions).
• IT Risk Assessments and Data Privacy, Data compliance related tasks.
• Support Supplier Assessments and provide guidance.
• Perform end to end validation activities for IT projects and system releases/upgrades.
• Define test strategy and review test cases in accordance with test plan.
• Support in Internal audit and inspections.

Qualifications

• Bachelor’s or master’s degree in engineering, computer science (or equivalent) with Min 6+ years of experience in working in a service level-based organization in the IT quality domain.
• Min 4 years of practical experience in GxP areas with exposure to regulatory affairs.
• Min 6+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities.
• Experience in compliance documentation, deviation and CAPA management.
• Experience in periodic reviews, regulatory compliance, data compliance, GDPR (General Data Protection Regulation).
• Experience in IT tools like ServiceNow, Testing tools, etc.
• Excellent verbal and written communication skills.

About the department

CVT CoE as part of the xDD&IT Services department, is the unit responsible for supporting compliance, validation and test management of multiple IT systems across Novo Nordisk. The systems are used on a global scale by many areas of the business, including R&D, PSQ etc. and are critical to the execution of key business process such as development, manufacturing, sales, finance etc. CVT CoE focuses on delivering harmonised support services related in the Compliance, Validation and Testing areas.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here – to ensure that people can lead a life independent of chronic disease.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline

26th Sep 2023.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.