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Open nowPosted 9 days ago

Validation Engineer

EURES job mobility portal110,373 open roles

Where
Roeselare, Belgium
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Your applicationOpen nowValidation EngineerEURES job mobility portal · Roeselare, Belgium

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  2. CV RocketCV written for this posting.

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

  4. CV RocketApplied on EURES job mobility portal's own form.

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The clock on this job

Early applications get read.

7.7% 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. 3.3%3 days
  3. 7.7%7 days
  4. 14.0%14 days
  5. 33.7%30 days
This job: posted 9 days ago

The posting

Als brug tussen ons IT en QESH-team in België is Poulpharm op zoek naar een Validation Engineer.

Ben jij geboeid door kwaliteit, IT en validatie? Werk je graag gestructureerd en krijg je energie van het bewaken van GxP-compliance binnen een internationale omgeving? Dan ben jij misschien de validation engineer die we zoeken.

Wat houdt de job in?

Als Validation engineer zorg je ervoor dat onze geïnformatiseerde systemen voldoen aan de geldende kwaliteits- en regelgevingsvereisten.

Je taken omvatten onder andere:

  • Begeleiden van de volledige validatielevenscyclus van geïnformatiseerde systemen, van implementatie tot uitdienstname.
  • Opstellen, uitvoeren en onderhouden van validatiedocumentatie, zoals validatieplannen, gebruikersvereisten, risicoanalyses en testprotocollen.
  • Bewaken van de gevalideerde status van systemen door wijzigingen, periodieke reviews en verbeteracties correct op te volgen binnen mastercontrol.
  • Waken over de naleving van de geldende kwaliteitsrichtlijnen, regelgeving en principes rond data-integriteit.
  • Samenwerken met IT, QESH, de verschillende laboratoria en externe leveranciers bij de implementatie, wijziging en validatie van systemen.
  • Ondersteunen van interne en externe audits en meewerken aan de opvolging van auditbevindingen.
  • Opstellen van gebruikersprocedures en geven van opleidingen zodat systemen correct en conform worden gebruikt.

Je werkt hiervoor nauw samen met collega’s van het QESH-team, IT, de verschillende laboratoria en externe partners.

Wat verwachten wij van jou?

  • Een master- of bachelor in een wetenschappelijke, (bio)technische of informaticarichting, of bent gelijkwaardig door ervaring.
  • Je hebt 3 tot 5 jaar relevante ervaring met Computer system validation binnen een GxP-omgeving.
  • Je bent vertrouwd met relevante kwaliteitsrichtlijnen en regelgeving, zoals GAMP 5, ISO-normen, data-integriteit en de geldende regelgeving voor gevalideerde systemen
  • Je werkt nauwkeurig en gestructureerd.
  • Je kan zelfstandig werken en neemt verantwoordelijkheid voor je projecten
  • Je werkt graag samen met verschillende teams.
  • Je communiceert vlot in het Nederlands en Engels
  • Ervaring met mastercontrol en/of testo is een plus.
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