Global Lead IT Computer System Validation (CSV) | Brussels, Prothya Biosolutions

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Solliciteren

Plaats

Brussels
België
be

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2026-03-05

Online to:

2026-05-04
EUR 20.00 HOUR

Global Lead IT Computer System Validation (CSV) | Brussels

Prothya Biosolutions
België
11 uren geleden

ph3Global Talent Manager @ Prothya (part of Accord Healthcare) /h3 pbLocation: /b Prothya Biosolutions Belgium - Neder-Over-Heembeek (with occasional travel to Amsterdam) /p pbDepartment: /b IT /p pbReports to: /b Enterprise IT Architect. /p pAre you a seasoned expert in Computer System Validation (CSV) with a passion for quality, compliance, and innovation in the pharmaceutical industry? At Prothya Biosolutions, we’re looking for a bGlobal Lead IT CSV /b to drive validation excellence across our computerized systems and ensure they meet the highest regulatory standards. /p pAs our Global Lead for IT CSV, you’ll lead validation efforts across the organization, ensuring systems are fit for purpose, compliant, and aligned with GxP requirements. You’ll collaborate with cross-functional teams, mentor IT professionals, and shape validation strategies that support operational efficiency and regulatory compliance. /p ul libDevelop Validation Strategies /b /li liDesign tailored validation approaches aligned with user needs, system requirements, and global regulations (GAMP, EU Annex 11, FDA 21 CFR Part 11). /li libExecute Validation Protocols /b /li liLead IQ/OQ/PQ activities, coordinate testing, document results, and manage deviations in line with internal CSV procedures. /li liEvaluate GMP-criticality of systems and changes, identify compliance gaps, and implement mitigation strategies. /li liEducate IT teams on CSV processes and regulatory expectations. Act as the go-to expert for system qualification and validation. /li liReview and enhance validation processes based on industry trends and regulatory updates to boost efficiency and compliance. /li libManage Documentation /b /li liOversee creation and storage of validation documentation, ensuring audit-readiness and proper archiving. /li libCollaborate Across Functions /b /li liWork closely with IT, Automation, Production, QA, QC, Medical Affairs, and Supply Chain to align validation strategies and decisions. /li liMinimum b5 years of experience /b in CSV, ideally within the pharmaceutical sector. /li liProven track record in validation strategy development, risk assessments, and execution of validation protocols. /li liStrong knowledge of bGAMP5, 21 CFR Part 11, EU Annex 11 /b, and pharmaceutical quality systems. /li liConceptual understanding of IT and IT-OT architecture, including networks, applications, and automation systems. /li liExperience with bDocument Management Systems /b and bQuality Management Systems /b. /li liFluent in bEnglish /b; Dutch is a plus. /li liAnalytical, pragmatic, and collaborative mindset. /li liAble to handle time pressure and influence quality outcomes across systems. /li /ul pbOur Company /b /p pProthya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn! /p pbWe offer /b /p pProthya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training. /p pIn return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year. /p pWe also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months). /p pFurthermore, we value mutual respect and diversity is our strength. /p pAt Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn! /p pbAre you moving along? Then apply now! /b /p pReferrals increase your chances of interviewing at Prothya Biosolutions by 2x /p /p #J-18808-Ljbffr

Solliciteren

Global Lead IT Computer System Validation (CSV) | Br...

Plaats

Contract

Datum gepubliceerd

Online to:

Global Lead IT Computer System Validation (CSV) | Brussels

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