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Open nowPosted 7 days ago

QA Specialist Utilities & Equipment

EngiFlex117 open roles

Where
Mechelen, Belgium
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Your applicationOpen nowQA Specialist Utilities & EquipmentEngiFlex · Mechelen, Belgium

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  2. CV RocketCV written for this posting.

  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. EngiFlex postings stay open a median of 5 days.

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 7 days ago

EngiFlex median: 5 days open

The posting

Functieomschrijving

Jouw rol als QA Engineer Utilities & EquipmentAls QA Engineer Utilities & Equipment bewaak je de kwaliteit en compliance van technische systemen binnen een GMP-omgeving. Je stemt dagelijks af met de technische dienst en ziet erop toe dat equipment, utilities en bijbehorende servicecontracten beantwoorden aan de geldende kwaliteitsvereisten. Vanuit jouw QA-kennis ondersteun je projecten, changes en kwalificatieactiviteiten. Je vormt daarbij de schakel tussen Quality en Technical Operations.

Je beoordeelt documentatie en risico's en volgt op dat installaties en systemen compliant worden opgeleverd. Met jouw kritische blik en kennis van GMP draag je bij aan een veilige en kwaliteitsgerichte productieomgeving.

Je verantwoordelijkheden

  • Documentatie rond utilities en equipment reviewen en goedkeuren
  • Wijzigingen, afwijkingen en CAPA's binnen technische processen beoordelen
  • Kwalificatie- en validatieactiviteiten voor installaties en systemen ondersteunen
  • Samenwerken met de technische dienst om projecten conform de kwaliteitsvereisten op te leveren
  • Kwaliteitsvereisten opvolgen binnen servicecontracten, zoals pest control, onderhoud en kalibraties
  • Document reviews uitvoeren en de GMP-compliance bewaken
  • Stakeholders adviseren over kwaliteitsvragen binnen Technical Operations en QA-gerelateerde topics

Je werkt nauwkeurig, bent kwaliteitsbewust en stelt je kritisch op wanneer de situatie daarom vraagt. Je communiceert vlot met verschillende stakeholders en slaagt erin een goede samenwerking op te bouwen tussen Quality en technische teams. In een gereguleerde omgeving behoud je het overzicht en neem je verantwoordelijkheid op voor je dossiers.

Wat breng je mee?

  • Een bachelor- of masterdiploma in een wetenschappelijke of technische richting
  • Minstens 3 jaar ervaring in een QA-functie binnen een GMP-omgeving
  • Ervaring met utilities, equipment en technische installaties
  • Ervaring in samenwerking met een technische dienst of binnen een engineeringomgeving
  • Een vlotte kennis van Nederlands en Engels
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