ph3Role Overview /h3pThe 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: /pulliSupports validation projects of computerized systems using the Computer Software Assurance (CSA) method as validation team lead (Validation Manager). /liliProvides guidance to development teams on using Polarion in validation projects. /liliPrepares procedures and work instructions to support qualification and validation of computerized systems. /liliConducts auditing of software vendors and suppliers. /liliReviews and audits GMP-compliant qualification and validation of corporate computerized systems used in the Digital Operations department. /liliTrains development teams in CSA and general validation principles within the Digital Operations department. /liliContinuously improves the CSA validation process as implemented in the department. /liliEnsures that computer software validations are compliant and consistent with relevant regulations and guidelines. /liliEnsures that QM principles are followed in validation projects. /liliEscalates if CSA principles are disobeyed. /liliRe‑qualifies / re‑audits software vendors and suppliers to maintain their qualified status. /li /ulh3Key Responsibilities /h3ulliProvide validation guidance in validation projects of computerized systems according to CSA as validation team lead (Validation Manager). /liliSupport development teams using Polarion in validation projects.



/liliPrepare procedures and work instructions to support qualification and validation of computerized systems. /liliAudit software vendors and suppliers. /liliReview and audit GMP‑compliant qualification and validation of corporate computerized systems used in Digital Operations. /liliTrain development teams in CSA and general validation principles. /liliContinuously improve the CSA validation process. /liliEnsure compliance of software validations with regulations and guidelines. /liliEnsure QM principles are followed. /liliEscalate when CSA principles are disobeyed. /liliRe‑qualify / re‑audit software vendors and suppliers to maintain their qualified status. /li /ulh3Skills Experiences /h3ulliAcademic degree (Master or comparable). /liliProfound experience in computerized system validation / computer software assurance. /liliGood knowledge of EU GMP Annex 11, US FDA 21 part 11, and GAMP 5. /liliKnowledge and understanding of corporate SOPs and Wis related to computer software validation and Quality and Risk Management. /liliGood knowledge of ServiceNow, Polarion and Office, and basic knowledge of QM principles. /liliProactive working and prioritizing tasks according to validation project requirements. /liliCritical, creative, and problem‑oriented thinking in validation projects. /liliTeam player with good soft skills, leadership skills, high motivation, decision‑making ability and reliability. /liliExperience and readiness to work in multicultural and changing teams. /liliGood presentation and problem‑solving skills. /liliExcellent English language skills. /liliGlobal travelling readiness. /li /ul /p #J-18808-Ljbffr

📌 (Senior) Validation Expert for Computerized Systems (m/f/d)
🏢 100055 Fresenius Kabi Deutschland
📍 Barcelona