About The RoleThe 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 Operations department.
Continuous improvement of CSA validation process as implemented in Digital Operations department.
Assure that computer software validations are done compliant and in consistency with relevant regulations and guidelines.
Assure that QM principles are followed in validation projects.
Escalation if CSA principles are disobeyed.
Re-qualify / re-audit software vendors and supplier to maintain their qualified status.
Your Skills And Experiences
Academic degree (Master or comparable degree).
Profound experience in computerized system validation / computer software assurance.
Good knowledge of EU GMP Annex 11, US FDA 21 part 11 and GAMP 5.
Knowledge and understanding of corporate SOPs and Wis related to computer software validation and Quality and Risk Management.
Good software knowledge (Se