IT Validation Specialist

2 weeks ago

Bengaluru, Karnataka, India Novo Nordisk AS Full time

About the Role

We are seeking an IT Validation & Compliance Specialist I to join our Site Collaboration Solutions team at Novo Nordisk. The successful candidate will have a strong background in IT validation and compliance, with experience in performing activities related to Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with Novo Nordisk Quality Management System (QMS).

Key Responsibilities

  • Performing activities related to CSV/CSA in line with Novo Nordisk QMS, including validation for GxP Computerized Systems/ Computerized Equipment both in project and operations phase.
  • Participating 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.
  • Preparing the Release plan for releases and driving all the release related activities.
  • Defining test strategy, managing test execution, review and reporting in line with Software Testing Life Cycle (STLC) including handling validation deviations. Performing CAPA and RCA using 5 x Why/ approach or any similar approach.
  • Defining a risk-based validation strategy & executing in line with Novo Nordisk QMS. Acting as an SME for Validation activities and executing the validation strategy both in Agile and V Model as necessary.

Requirements

  • Bachelor's or Master's in a 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 A/S is a global healthcare company with a strong commitment to improving the lives of people with chronic diseases. We are a leader in diabetes care and also have a significant presence in haemophilia care. Our products and services are designed to make a meaningful difference in the lives of our patients and customers.

What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. Our team is passionate about making a difference in the lives of our patients and customers, and we are looking for like-minded individuals to join us.

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