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Open nowPosted 47 hours ago

QA Specialist MES | Pharma | Beerse

SELECT PROJECTS (Select)

Where
Turnhout, Belgium
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Your applicationOpen nowQA Specialist MES | Pharma | BeerseSELECT PROJECTS (Select) · Turnhout, Belgium
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  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted 47 hours ago

The posting

Jouw baan als QA Specialist MES

Wil jij mee bouwen aan de productieomgeving van de toekomst binnen een internationale farmaceutische speler? Als QA Specialist MES werk je op een site waar kwaliteit, innovatie en patiëntveiligheid centraal staan. Je ondersteunt de implementatie en optimalisatie van een nieuw MES-systeem binnen Device Assembly en Parenteral Packaging. Daarbij ben je de schakel tussen Quality, Operations en projectteams. Dankzij jouw expertise zorg je ervoor dat processen voldoen aan de hoogste GMP- en kwaliteitsstandaarden. Je krijgt de kans om impact te maken op zowel operationele activiteiten als strategische verbeterprojecten.

Gelukkig kunnen we op jou rekenen bij het:

  • Beoordelen en goedkeuren van MES-masterdata en productie-instructies
  • Bewaken van GMP-compliance binnen Device Assembly en Packaging
  • Ondersteunen van het MES-project vanuit kwaliteitsstandpunt
  • Uitvoeren van QA-review en goedkeuring van GMP-documentatie
  • Adviseren van projectteams over kwaliteits- en compliancevereisten
  • Optimaliseren van workflows rond wijzigingen en batchdocumentatie
  • Fungeren als Quality Point of Contact voor stakeholders

Je werkt gestructureerd, communiceert vlot met verschillende stakeholders en kan onder tijdsdruk weloverwogen beslissingen nemen. Dankzij jouw analytische blik weet je risico's correct in te schatten en draag je actief bij aan verbeteringen binnen de organisatie.

Wat breng je mee?

  • Masterdiploma in farmaceutische, chemische of biologische wetenschappen of engineering
  • Minstens 5 jaar ervaring binnen de farmaceutische industrie
  • Ervaring met verpakkingsprocessen, batch records en batch release
  • Kennis van MES-systemen en GMP-regelgeving
  • Vlotte kennis van Nederlands en Engels, zowel gesproken als geschreven

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