Associate Business Analyst II - Validation

Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bringing attention to key business challenges? Then we might have the right position for you.

About the department

Global Information Technology (IT) India was established in February 2010 as an integral part of Global IT in Head Quarter. The establishment of Global IT India is in line with the overall IT strategy in Novo Nordisk, which is to globalise IT in Novo Nordisk. From the beginning in 2010, the unit has grown to 300+ employees till date. The main role of Global IT India is to ’manage’ IT, which includes system management, project management, infrastructure management, compliance management, security management, process management and vendor management.

The position

As a Business Analyst, you will be responsible for performing various tasks related to Computerised System Validation (CSV) and have good understanding of CSV. We expect you to have an excellence in compliance and process understanding and Quality Management system. You will be able to take up IT quality coordinator roles at various stages of IT project. You will be responsible for preparing Master Validation Plan/Report, Quality/Validation Plan/Report, IT Quality Risk Assessment and drive the Quality Risk assessment, Qualification Protocol/Report. You will be responsible for reviewing and approving (on behalf of NN QA) the following validation documentation established under Novo Nordisk QMS which include f unctional and technical design Specifications URS level such as I QP/R, OQP/R, XQP/R, p-IQP/R and p-XQP/R. Furthermore, we expect you to involve in test execution and reporting and you will be responsible for performing gap assessments against current 21 CFR Part 11 and EU Annex 11 regulatory requirements. You will be responsible for authoring/reviewing yearly reports and IT Periodic evaluation reports with respect to user setup and configuration management. You will be responsible for managing and maintaining periodic report tools. We expect you to contribute towards achievement of project goals and demonstrate Pro-activeness and ownership.

In addition to the above, you will be responsible for managing own time planning, multiple concurrent tasks, timely deliverables and be flexible. You will be involved in communicating with relevant stakeholders. You will be responsible for enhancing good team spirit and high degree of knowledge sharing. You will be responsible for deliver specific services that fulfil productivity/cost/quality/Timeliness KPI Criteria for stakeholders. We expect you to develop plans, execute and deliver the services with acceptable service evaluations. We expect you to ensure stakeholders evaluations are acted upon and ensure all service hours are logged accurately in CPT. You will be responsible to read and understand all documentation related to IT shared services. You will be responsible to keep all documentation on relevant services up to date. You will be responsible to regularly communicate with management on the service status on improvement activities.

Qualification

Below skills are required to have

• MCA, M.Sc., B.SC. BE or similar graduate degree in relevant field (Computer Science, IT Quality)

• Preferred to have Industry recognised ITIL and ISO quality management certification

• Excellent communication skills in English and comfortable working with different cultures

• Min 7+ years of experience in working in a service level-based organisation/ pharmaceutical industry preferably in the IT quality domain

• Min 3+ years of practical experience in GxP areas with exposure to regulatory affairs

• Min 3+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities

• Good knowledge on regulatory requirements as well as internal requirements to keep systems within responsibility in compliance

• Broad knowledge of basic IT technologies to be able to understand, and challenge decisions made by IT QA

• Very good understanding of GAMP

• Good interpersonal skills

• Ability to collaborate and communicate with stakeholders and external parties

• Ability to represent NN in relations with users and external stakeholders

• Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11)

• Large degree of flexibility and the ability to work under strong time pressure

• Inspire and motivate team

Working at Novo Nordisk

In Novo Nordisk, you will be met with trust, interesting challenges and rich opportunity for personal and professional growth. You will be investing your unique skills in an environment focused around a competent sharing of knowledge, and where your talent and experience is valued. We are proud to use our dedication and our capabilities to make a difference for millions of people around the world.

Contact

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

Deadline

30 June 2021.

Millions rely on us

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward 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 to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.