Job Description

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Advanced Business Analyst II

Category: Digital & IT

Location:

Bangalore, Karnataka, IN

Department Name - Cross IT Services

At Novo Nordisk, we strive to be at the forefront of digital healthcare and to succeed with this, we need many bright minds. Working directly or indirectly with all parts of Novo Nordisk Globally, you will play a significant part in leading Novo Nordisk towards the future of digital healthcare securely. We are looking for an Advanced Business Analyst II for our Cross-IT Services Unit. Join a growing team, working in an international environment. Apply now!

About the department
Cross IT Services is the unit responsible for compliance management of systems at Novo Nordisk in areas like: Global IT, PS, CMC, NNIO and NNI etc. The systems are used on a local, regional, and global scale by many areas of the business, including R&D, Sales and Marketing, Production sites etc. and are critical to the execution of key business process such as development, manufacturing, sales, finance, etc. This unit is responsible for validation these systems/ Qualification of underlying infrastructure and maintaining the systems in the validated state throughout in its operation.

The Position
As an Advanced Business Analyst II, you will be responsible for performing various tasks related to Testing. You will be responsible for performing activities related Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with Novo Nordisk Quality Management System (QMS) like validation for GxP Computerised Systems/ Computerised Equipment both in project and operations phase. Service Management responsibility for multiple projects. You will be entrusted with the below responsibilities:

• Define a risk-based validation strategy & execute in line with Novo Nordisk QMS. Act as an SME for Validation activities and execute the validation strategy both in Agile and V Model as necessary.
• Define test strategy, manage test execution, review and reporting in line with STLC including handling validation deviations. Perform CAPA and RCA using 5 x Why/ approach or any similar approach.
• Participate in audits and inspections including finding solutions to compliance gaps identified in audit/ inspections. And provide compliance consulting for IT activities.
• End to end service delivery management of the assigned/owned services.
• Perform stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. Ensure service is delivered in compliance with internal and external requirements. Develop training materials related to business process CSV and CSA.

Qualifications

• Bachelors or Masters in relevant field with minimum 6+ years of experience in working in a service -based organization/pharmaceutical industry preferably in the IT quality domain.
• Preferred to have Industry recognized ITIL and ISO quality management certification.
• Minimum 4 years of practical experience in GxP areas with exposure to regulatory affairs and 2+ years in performing RCAs, CAPA and any other relevant IT quality activities.
• Experience in Risk assessment (IT RA, Quality, Functional, DI, Supplier) and exposure to Test management tools such as HP ALM.
• Experience with both waterfall and Agile methodology, supplier assessment, deviation handling, change management is required.
• Good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11.
• Expert in performing validation activities for complex projects and ability to represent NN in relations with users and external stakeholders.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That\'s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working towards something bigger than ourselves, and it\'s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we\'re life changing.

Contact

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

Deadline

14 Dec 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