CSV Specialist II

Location

Bangalore | India

Job description

Job description

Are you an expert in IT systems Validation and Compliance Do you have experience in handling the compliance in all stages from Projects to Operations We are looking for an Senior Compliance Specialist to join our team in Intelligent Automation CoE. If you are ready for a new challenge and want to make a difference, read and apply today for a life-changing career.

About the Department

Intelligent Automation CoE (IA CoE) department leads a key IT innovation initiative in DD&IT, responsible for automating processes by developing, supporting, and maintaining Automation Technologies in Novo Nordisk.

The position

As an Senior Compliance Specialist, you will have the following responsibilities:

• Drive the compliance activities for Intelligent Automation CoE.
• The individual will be the subject matter expert (SME) for key compliance activities and a sparring partner for all GxP based Automations .
• Drive the yearly compliance wheel activities and ensure compliant state for all tracks
• Participate in audits and inspections and get the team adequately prepared.
• Work with internal teams including ITQA, Process Office, and track leads to simplify and maintain a high level of compliance.

Qualifications

• Bachelor's degree in computer science, or similar qualification.
• Overall 10+ years of experience with a minimum of 4 years as Validation/Test lead.
• Good knowledge of 21 CFR XX, Predicate Rules, concepts of validation.
• Experience with testing RPA applications is a good to have.
• Experience in Agile methodology.
• Good knowledge on business/functional validations, GxP awareness.
• Ability to collaborate and communicate with stakeholders, vendors, and consultants.
• Excellent communication skills, comfortable working with different countries across multiple time-zones
• Strong presentation, verbal, and written communications skills.
• High degree of flexibility and good interpersonal skills

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 energies 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).

Deadline

13- 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