Role Overview

The Team Computer Software Assurance ensures that applications developed in Digital Operations – Manufacturing IT are validated according to significant regulations and guidelines. Therefore the team operates a validation support tool (Polarion by Siemens) to support the development team in the validation process and fosters the following:

• Supports validation projects of computerized systems using the Computer Software Assurance (CSA) method as validation team lead (Validation Manager).
• Provides guidance to development teams on using Polarion in validation projects.
• Prepares procedures and work instructions to support qualification and validation of computerized systems.
• Conducts auditing of software vendors and suppliers.
• Reviews and audits GMP-compliant qualification and validation of corporate computerized systems used in the Digital Operations department.
• Trains development teams in CSA and genera...