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Open nowPosted 6 days ago

CSV engineer & site key user (checklyst manager) - regio Antwerpse Kempen

RANDSTAD PROFESSIONALS

Where
Turnhout, Belgium
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Your applicationOpen nowCSV engineer & site key user (checklyst manager) - regio Antwerpse KempenRANDSTAD PROFESSIONALS · Turnhout, Belgium

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  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

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The clock on this job

Early applications get read.

12.7% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted 6 days ago

The posting

In deze unieke functie verdeel je jouw expertise perfect 50/50 over QA-CSV toezicht op kritische productiesystemen én hou je de regie als site key user voor checklyst manager.

Jouw verantwoordelijkheden als site key user checklyst manager (50%)

  • coördineren van het ontwerpen, testen, goedkeuren en vrijgeven van nieuwe digitale checklists en berekeningsbestanden
  • onboarding & coaching: nieuwe afdelingen en teams meenemen in het systeem, trainingen verzorgen en eerstelijns functionele ondersteuning bieden
  • beheren van gebruikerstoegang, rollen, functiescheiding (segregation of duties) en het bewaken van systeem- en processtatistieken (metrics)
  • borgen dat systeemdossiers tijdig worden afgesloten en de governance op site niveau naar een hoger niveau tillen

Jouw verantwoordelijkheden als CSV engineer (50%)

  • systeemscope: PLC & SCADA visualisatie, deeltjes- en omgevingsmonitoring, automation network shared services (AD, Backup & Restore, SIMATIC Logon, Patching, Antivirus, Dataoverdracht)
  • validatie-lifecycle: zorg dragen voor onafhankelijk QA-toezicht bij projecten, wijzigingen, periodieke evaluaties en uitfasering (retirement)
  • compliance & review: beoordelen en goedkeuren van validatiedocumentatie (URS, risicoanalyses, protocollen, rapporten, traceerbaarheid) en het afhandelen van deviations, CAPA’s en change controls
  • data integrity: bewaken van audit trails, toegangsbeheer, tijdsynchronisatie, dataflow-mapping en het borgen van inspectiebereidheid
  • bachelor of master in engineering, automatisering, informatica of een vergelijkbare technische/wetenschappelijke richting
  • ca. 5 jaar relevante ervaring met CSV, validatie, QA of geautomatiseerde systemen binnen een GxP-gereguleerde omgeving
  • goede operationele kennis van EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, SDLC en dataintegriteitsrichtlijnen (o.a. PIC/S)
  • ervaring met (of sterke begrip van) PLC/SCADA, netwerkinfrastructuur, digitale formulieren/workflows en change & deviation management
  • vertrouwd met het ondersteunen van systeemgebruikers of het optreden in een rol als key user
  • een achtergrond met checklyst manager is een pluspunt, evenals aantoonbare affiniteit met e-form tools, digitale kwaliteitsworkflows of paperless validation software
  • uitstekende kennis van het Engels en goede kennis van het Nederlands
  • organisatorisch sterk, analytisch en oplossingsgericht

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