16 Aug
|
Novo Nordisk
|
Bengaluru
16 Aug
Novo Nordisk
Bengaluru
Department Cross IT Services.
Are you experienced in IT validation and compliance within the pharmaceutical industryAre you looking for a new challenge in a global healthcare companyWe are seeking an IT Validation and Compliance Specialist I to join our Cross IT Services team at Novo Nordisk.
If you have a robust 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
📌 IT Validation and Compliance Specialist I (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru