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(Senior) Validation Expert for Computerized Systems (m/f/d) at 100055 Fresenius Kabi Deutschland GmbH

Language
Location
Warsaw, Masovian Voivodeship
Type
Full-time
Level
lead/mgmt
Posted

Description

The Validation Manager leads computerized system validation projects for Digital Operations – Manufacturing IT, supporting development teams with Polarion, preparing qualification and validation procedures, auditing software vendors, reviewing GMP-compliant validation, training teams, and improving CSA processes. The role requires a master or comparable degree, extensive computerized system validation or software assurance experience, knowledge of EU GMP Annex 11, US FDA 21 CFR Part 11, and GAMP 5, along with software, leadership, communication, and global-travel readiness.

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