Specialist I Csv And Csa Job In Novo Nordisk In India, Bengaluru / Bangalore

Job descriptionDoes your motivation come from challenges and working in a dynamic environment Are you innovative and passionate and one who thrives in fast- learning environment Are you enthusiastic about understanding the business and bringing attention to key business challenges Then we might have the right position for you Apply Now! About the Department Cross IT Services is the unit responsible for compliance management of systems at Novo Nordisk in areas like:DD&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, Patient Safety, 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 validating these systems/ Qualification of underlying infrastructure and maintaining the Validated status.

The Position As a Specialist, you will be responsible for performing activities in line with Computer System Validation (CSV)/ Computer Software Assurance (CSA) You will be responsible for validation for GxP Systems/ Compliance Responsible for Non-GxP Systems You will be additionally responsible for:

• Defining a risk-based validation strategy & execute in line with Novo Nordisk QMS You shall act as a SME for Validation activities and execute the validation strategy both in Agile and V Model as necessary
• Perform various assessments including IT Risk Assessment (ITRA), IT Requirements Risk assessment (ITRRA) Quality, functional, data integrity and supplier assessments.
  
  You will define test strategy, manage test execution, review, and reporting in line with STLC including handling validation deviations
• Perform CAPA and RCA end to end change management including handling deviations both during the project and operation phase
• Participate in audits and inspections including finding solutions to compliance gaps identified in audit/ inspections
• Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV/ CSA

You shallbe responsible as a Service Manager for multiple projects to provide end to end service delivery management of the assigned/owned services.

You shall manage offshoring discussions with new stakeholder You will perform effort estimation for the projects and define the resource allocation Challenge vendor suggestions, contracts, and estimations you will ensure service is delivered in compliance with internal and external requirements You will develop training materials related to business process Computer System Validation (CSV) and Computer Software Assurance (CSA).

Qualification

• MCA, MSc, BSC or similar graduate degree in relevant field (Computer Science, Life Sciences, IT Quality).
  
  A certification in ITIL and ISO quality management certification is preferred
• Minimum of 8+ years of experience in working in a pharmaceutical /service-based organization preferably in the IT quality domain
• 5+ years of practical experience in GxP areas with exposure to regulatory requirements and 5+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities
• 2+ years of experience in service management
• Must have good experience in validation of IT systems (LIMS/Track wise/Argus/SAP/Documentum/ServiceNow etc and CSV Deliverables.
  
  
• Must hold experience in Agile methodology for GxP Systems and qualification of GxP/non-GxP cloud solutions
• Exhibit good understanding of GAMP 5 and various regulatory requirements including CFR part 11, EU Annex 11, performing validation activities for complex projects
• Demonstrate an exceptional ability to work with stakeholders at the highest organisational level
• Must have excellent communication skills It shall be expected of you to be highly self-motivated to work independently, within delegated authority, with minimal or no supervision.
  
  
• Demonstrate the ability to work as part of a team, and a clear understanding of how assigned responsibilities impact other processes and the work of other people

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) Apply Now! Deadline 13th April 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 is looking for .

Novo Nordisk is looking for Any Graduate / Post Graduate profile candidates.