(Senior) Validation Expert for Computerized Systems (m/f/d)

Job description

About the role: The Team Computer Software Assurance ensures that applications developed in Digital Operations – Manufacturing IT are validated according the significant regulations and guidelines. Therefore the team operates a validation support tool (Polarion by Siemens) to support the development team in the validation process. In addition, the team fosters to follow the Fresenius Kabi QA principles in development activities. Your key responsibilities: - Support and validation guidance in validation projects of computerized systems according Computer Software Assurance (CSA) method as validation team lead (Validation Manager). - Support of the development teams in using a digital validation support tool (Polarion from Siemens) in validation projects. - Support and preparation of respective procedures and / or work instructions to support qualification and validation of computerized systems. - Auditing of software vendors and suppliers. - Review and auditing of GMP-compliant qualification and validation of corporate computerized systems as relevant and used in Digital Operations department. - Training of development teams in CSA and general validation principles within Digital Op...