IT Validation Specialist

2 weeks ago

Bengaluru, Karnataka, India Novo Nordisk Full time

Job Summary

Novo Nordisk is seeking a highly skilled IT Validation Specialist to join our team. As an IT Validation Specialist, you will be responsible for performing activities related to Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with Novo Nordisk Quality Management System (QMS). This includes validation for GxP Computerized Systems/ Computerized Equipment both in project and operations phase.

Key Responsibilities

  • Performing activities related to Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with Novo Nordisk Quality Management System (QMS)
  • Validation for GxP Computerized Systems/ Computerized Equipment both in project and operations phase
  • Service Management responsibility for multiple projects
  • Participate in audits and inspections including finding solutions to compliance gaps identified in audit/ inspections
  • Managing yearly periodic review reports, upkeeping audit readiness checklist and all system level documentation (e.g. risk assessments, plans, reports, requirements and specifications) up to date
  • Responsible for preparing the Release plan for releases and driving all the release related activities
  • Define test strategy, manage test execution, review and reporting in line with Software Testing Life Cycle (STLC) including handling validation deviations
  • Perform CAPA and RCA using 5 x Why/ approach or any similar approach
  • Define a risk-based validation strategy & execute in line with Novo Nordisk QMS
  • Act as an SME for Validation activities and execute the validation strategy both in Agile and V Model as necessary

Requirements

  • Bachelors or Masters in relevant field with minimum 8 to 10+ years in the IT or equivalent industry and minimum 4+ years of GxP Validation& CSV /Testing experience in working with pharmaceutical requirements
  • Experience in Risk assessment (IT Risk Assessment related to: Business Process, Solution, Data Integrity, IT Security, Functional, Supplier) and exposure to Test management tools such as HP ALM
  • Experience with supplier assessment, deviation handling, change management is required and good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11
  • Expert in performing validation activities for complex projects and ability to represent NN in relations with users and external stakeholders
  • Good to have experience in Agile methodology & waterfall methodology, usage of Azure DevOps (ADO) etc.
  • Experience in drafting test cases & reviewing test cases and approving test cases in Leapwork (Good to have) or any other automated test management tool
  • Good to have Industry recognized ITIL and Scaled Agile Framework (SAFe) 5 Practitioner
  • Excellent interpersonal and communication skills including verbal and written communication
  • Ability to represent NN in relation with users and external stakeholders
  • Minimum 5+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities

About Novo Nordisk

Novo Nordisk is a leading global healthcare company with a legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63, employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.

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