Job Location: Bengaluru
Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working 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 and join a growing team, working in an international environment.
About the department
Cross IT Services is the unit responsible for supporting compliance management of multiple IT systems in Novo Nordisk. These systems are used on a global scale by many areas of the business, including Research & Development, Early Development, Product Supply, Quality, Finance etc. and are critical to the execution of key business process such as development, manufacturing, sales, finance etc. Cross IT Services focuses on delivering harmonised support services related to the Compliance, Validation and Testing areas, thus supporting the maintenance of the systems in a validated state.
The Position
As a compliance consultant to IT Systems ensuring alignment to regulatory requirements and NN QMS.This position is responsible for performing various tasks related to Computerized System Validation (CSV) including:
- Periodic Reviews of the IT Systems including user reviews and maintaining the validated state of the IT System and Deviation Handling – Root cause analysis using 5 x Why approach or any similar approach and Corrective and Preventive Actions.
- IT Risk Assessments and Data Privacy related tasks
- Support Supplier Assessments and provide guidance. 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.
- Collaborate with stakeholders/partners with diverse interests, knowledge, cultural background, and personality. Manage multiple concurrent tasks and be flexible.
Qualifications
- 8+ years of experience in working in a service level-based organization preferably in the IT quality domain.
- Relevant experience of 3+ years on IT Validation.
- Practical experience in GxP areas with exposure to regulatory affairs.
- Manage compliance than core validation. Knows Good Automated Manufacturing Practice (GAMP), Control Objectives for Information Technologies (COBIT)
- Experience on performing Root cause analysis, Corrective and Preventive Actions and any other relevant IT quality assurance activities.
- Pharma Domain experience preferred.
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).
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Deadline
4th Nov 22.
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.
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