Specialist II

Location

Bangalore | India

Job description

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 a Specialist 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: Gobal 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.

Tha Position

Are you experienced in validation and compliance management for GxP Computerized Systems? Are you ready to take on the responsibility of ensuring systems are in compliance with regulatory requirements? We are looking for a Validation Specialist to join our Cross IT Services team at Novo Nordisk. If you have a strong background in validation and are passionate about ensuring quality and compliance, read on and apply today for a life-changing career. As a Validation Specialist at Novo Nordisl, you will have the following responsibilities:

• Define and execute validation and qualification strategies for GxP Computerized Systems, Computerized Equipment, Infrastructure, or Robotic Process Automation (RPA) and Emerging Tech such as Artificial Intelligence (AI) and Machine Learning (ML).
• Develop validation plans, validation reports, design reviews, test strategies, and execute validation activities.
• Ensure systems are in compliance with relevant internal and external regulatory requirements.
• Participate in audits and inspections, identifying and implementing solutions to compliance gaps.
• Provide compliance consulting for IT projects and deliver compliance deliverables related to CSV/CSA. Manage multiple concurrent tasks and be flexible in handling complex projects. Mentor and guide junior colleagues in validation activities.

Qulifications

To be successful in this role, we are looking for a candidate with the following qualifications:

• Bachelors or Masters in relevant field with minimum 10+ 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 5+ years of practical experience in GxP areas with exposure to regulatory affairs, 2+ years in performing RCAs, CAPA, 2+ years in service management 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 along with good stakeholder management skills.
• 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

22 March 2024.

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.

Job tags

Salary