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Open nowPosted 11 days ago

Compliance Engineer GMP Equipment Qualification

EURES job mobility portal298,592 open roles

Where
Turnhout, Belgium
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Your applicationOpen nowCompliance Engineer GMP Equipment QualificationEURES job mobility portal · Turnhout, Belgium

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The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 11 days ago

The posting

Functieomschrijving

Jouw rol als Compliance Engineer

Als Compliance Engineer werk je in een innovatieve farmaceutische omgeving waar kwaliteit, veiligheid en compliance centraal staan. Je speelt een belangrijke rol in kwalificatieprojecten voor equipment binnen productieomgevingen en zorgt ervoor dat zowel bestaande installaties als nieuwe systemen voldoen aan de geldende GMP-richtlijnen. Daarbij combineer je technische kennis met een sterke focus op documentatie, nauwkeurigheid en kwaliteit.

Je werkt samen met diverse stakeholders en draagt ertoe bij dat processen betrouwbaar, conform en toekomstgericht blijven functioneren.

Je verantwoordelijkheden omvatten onder meer:

  • Uitvoeren en coördineren van kwalificaties op productie-equipment.
  • Opstellen van kwalificatieprotocollen en samenvattende rapporten.
  • Vertalen van GMP-richtlijnen naar praktische kwalificatieactiviteiten.
  • Schrijven van URS-, FMEA-, DQ-, IQ-, OQ- en PQ-documentatie.
  • Uitvoeren van fieldwerk, zoals P&ID-controles en functionele testen.
  • Beheren van change controls, CAPA's en kwaliteitsincidenten.
  • Uitvoeren van PSQR's en meewerken aan verbeterinitiatieven.
  • Waken over data integrity binnen kwalificatie- en kwaliteitsprocessen.

Je werkt nauwkeurig en behoudt het overzicht in complexe projectomgevingen. Daarnaast communiceer je vlot met verschillende stakeholders en neem je verantwoordelijkheid voor de kwaliteit van je eigen werk. Je bent analytisch sterk en pakt problemen op een gestructureerde manier aan.

Hard skills

  • Masterdiploma of gelijkwaardig door relevante ervaring.
  • Minimaal 5 jaar ervaring in kwalificatie binnen een GMP-omgeving.
  • Sterke kennis van GMP, GDP en data integrity.
  • Ervaring met IQ, OQ en PQ binnen kwalificatietrajecten.
  • Ervaring met Trackwise of vergelijkbare kwaliteitssystemen.
  • Goede kennis van Nederlands en Engels, mondeling en schriftelijk.
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