IT Validation

2 months ago

Bengaluru, India Novo Nordisk AS Full time

Department: Site Collaboration Solutions (DD&IT Development)

Are you passionate about IT validation and compliance? Do you have a knack for ensuring systems meet regulatory requirements? We are looking for an IT Validation & Compliance Specialist I to join our Site Collaboration Solutions team at Novo Nordisk. If that sounds like you, read on and apply today for a life-changing career.

About the department

DD&IT (Digital, Data & IT) Development is the unit responsible for over 70 DD&IT systems at Novo Nordisk including the operation, maintenance, support and development of these systems. The systems are used on a global scale by all areas of the business from R&D to Sales and are critical to the execution of key business processes such as development, manufacturing, sales and submissions. This position is anchored within DD&IT Development unit in DD&IT GBS India in the department Site Collaboration Solutions. The Site Collaboration Solution department manages IT systems responsible for setting up trials, distributing relevant documents to clinical sites. The team which is basically composed in an ART set up also ensures interactions with clinical sites, investigators and clinical staff with regards to different IT support as well as development.

The position

As an IT Validation & Compliance Specialist I at Novo Nordisk, you will have the following responsibilities:

Performing activities related Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with Novo Nordisk Quality Management System (QMS) like 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.

Qualifications

To be successful in this role, you should have:

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.

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