Specialist-I Validation

Are you specialised in testing and validating IT applications? Would you like to be a part of a team who makes a difference for patients, testing important application that is the tool to evaluate risk for patients? Are you ready to cooperate with stakeholders across the whole organisation? If so, here is a challenging and exciting job opportunity as a Specialist Validation Analyst.

The position

As a Specialist Validation Analyst, you will be working in an engaging and multi-cultural environment with continuous expansion. You will be part of global cross-functional IT team.

Your main responsibilities will be:

• Driving the validation process e2e in close collaboration with stakeholders, IT QAs and your colleagues within the team working with IT development and validation across Denmark and India
• Analyzing and understanding the business requirements to plan an effective testing methodology
• Testcase design, review, execution, and documentation
• Execute all levels of testing (System test/Dry Runs/Regression and Deployment)
• Creating reports on daily/weekly/monthly basis to all stakeholders,
• Taking initiatives which are required to interpret and make valuable decisions regarding drug safety issues in an environment with complicated and changing legal requirements and guidelines,
• Being a point of contact for validation during audit and inspections,
• Critically evaluating existing procedures to suggest optimization and automation of application and report generation (LEAN thinking).

Qualifications

To succeed in this role, you need:

• University degree in a computer science/pharmaceutical science discipline or other relevant background
• Ideally 8+ years of experience in manual testing/validation, preferably with identification of the scope for automation of the test cases
• Experience with validation/testing documentation systems like TIMS or Azure DevOps
• Experience in validation of Business Intelligence (BI) application/ experience from the Pharma or Medical Device industry is an advantage
• Preferably good knowledge on STLC and SDLC
• As an advantage the knowledge of GxP requirements and best practices of 21 CFR Part 11, EU Annex 11, IT Compliance & CSV
• High level communication skills in English both written and spoken (company language)

On a personal level you need really good communication and coordination skills, as you will work with many different stakeholders. You have a strong analytical, consultancy mind-set and have an eye for a detail. Finally, you define yourself as proactive, goal orientated and self-driven person being able to follow through with the project.

About the department

Safety Reporting and Systems Support (SRSS) is part of Global Safety within R&D and we safeguard our patients all around the world and across all Novo Nordisk’ products.

SRSS plays an important role in supporting all our colleagues across Global Safety to collect data in an efficient way, secure the data quality and make the medical evaluation by delivering IT solutions for safety reporting and analysis. Furthermore, we deliver IT solutions and support to follow up on and optimize our business processes.

We are 15+ people in SRSS with IT and/or pharma/life science background working with Business Intelligence, Analytics and Data collection solutions in Bagsværd/DK and Bangalore/India. We are also looking into utilizing more advanced analytics like AI to get even better insight and Automated testing to improve efficiency.

Working at Novo Nordisk

At Novo Nordisk your skills, commitment and ambition help us change lives for diabetes patients for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.

Contact

For further information please contact Sivanesan at BSVB@novonordisk.com

Deadline

10 July 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.