IT Validation and Compliance Specialist I

3 months ago

Bengaluru, India Novo Nordisk AS Full time

Department – Cross IT Services

Are you experienced in IT validation and compliance within the pharmaceutical industry? Are you looking for a new challenge in a global healthcare company? We are seeking an IT Validation and Compliance Specialist I to join our Cross IT Services team at Novo Nordisk. If you have a strong background in computer system validation and a passion for ensuring regulatory compliance, then read on and apply today for a life-changing career.

About the department.
Cross IT Services is the unit responsible for compliance management of systems at Novo Nordisk in areas. The systems are used on a local, regional, and global scale by many areas of the business, including 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 validation these systems/ Qualification of underlying infrastructure and maintaining the systems in the validated state throughout in its operation.

The position 
As an IT Validation and 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. 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. 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. Participate in audits and inspections including finding solutions to compliance gaps identified in audit/ inspections. And provide compliance consulting for IT activities. End to end service delivery management of the assigned/owned services. Perform stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. Ensure service is delivered in compliance with internal and external requirements. Develop training materials related to business process CSV and CSA.

Qualifications

To be successful in this role, you should have the following qualifications: Bachelors or Masters in relevant field with minimum 6+ years of experience in working in a service -based organization/pharmaceutical industry preferably in the IT quality domain. Preferred to have Industry recognized ITIL and ISO quality management certification. Minimum 4 years of practical experience in GxP areas with exposure to regulatory affairs and 2+ years in performing Root Cause Analyst (RCA), CAPA and any other relevant IT quality activities. Experience in Risk assessment (IT RA, Quality, Functional, DI, Supplier) and exposure to Test management tools such as HP ALM. Experience with both waterfall and Agile methodology, supplier assessment, deviation handling, change management is required. 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.

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