Job Description

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Advanced Business Analyst I - IT Compliance and Validation

Category: Information Technology & Telecom

Location:

Bangalore, Karnataka, IN

At Novo Nordisk, we don\'t wait for change. We drive it! We are a dynamic company in an even more dynamic industry, and we know what got us here, will not necessarily make us successful in the future. Are you looking for the opportunity to make our patients\' lives better and leave your footprint? Novo Nordisk Global Business Services is a very strong Global IT business unit and has a thriving team of more than 600 technology professionals who support our company\'s mission through multiple functional domains of technology. Apply Now!

About the department

Cross IT Services is the unit responsible for compliance management of IT systems at Novo Nordisk in areas like Digital, Data & IT, Product Supply, Chemistry Manufacturing & Control etc. The systems are used on a global scale by many areas of the business, including Research &Development, Patient Safety etc and are critical to the execution of key business process such as development, manufacturing, sales, finance, etc. This unit is responsible for validating the systems/ Qualification of underlying infrastructure and maintaining the validation status.

The position

As an Advance Business Analyst, you will

• Responsible to perform Computerized System Validation (CSV)/Computer System Assurance (CSA) that includes defining a risk-based validation strategy and deliverable.
• Responsible to perform compliance related tasks provided as services from the department and provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV.
• Responsible to perform CAPA and RCA using 5 x Why approach or any similar approach with gap assessments against current 21 CFR Part 11 and EU Annex 11 regulatory requirements.
• Manage and maintain periodic report tools and review yearly reports of User Setup, Configuration Management, IT Periodic evaluation Reports to compliance with NovoNordisk Quality Management system.
• Responsible to conduct review meetings and coordinate with various stakeholders as a part of delivering services.

Your Qualifications:

• MCA, M.Sc., B.SC. or similar graduate degree in relevant field (Computer Science, IT Quality).
• ITIL and ISO quality management certification is preferred.
• Should have minimum 6+ years of experience in a service level based organization preferably in the IT quality domain.
• Should have minimum 4+ years of practical experience in GxP areas with exposure to regulatory affairs with performing RCAs, CAPA and any other relevant IT quality assurance activities.
• Excellent knowledge on regulatory requirements as well as internal requirements to keep systems within responsibility in compliance.
• Strong knowledge of basic IT technologies to be able to understand, and challenge decisions made by IT QA.
• Strong understanding of GAMP.
• Should have experience in stakeholders management.
• Knowledge of and experience with regulatory requirements (e.g., GMP, 21 CFR Part 11).
• Excellent communication skills.
• Large degree of flexibility and the ability to work under strong time pressure

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 energies 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)

Apply Now!

Deadline

31st Jan 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.

Novo Nordisk