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Open nowPosted 5 days ago

Validation & Engineering Officer Equipment

KELA

Where
Turnhout, Belgium
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Your applicationOpen nowValidation & Engineering Officer EquipmentKELA · Turnhout, 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 KELA's own form.

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The clock on this job

Early applications get read.

12.9% 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. 4.7%3 days
  3. 12.9%7 days
  4. 21.0%14 days
  5. 35.6%30 days
  6. 58.5%60 days
This job: posted 5 days ago

The posting

Als Validation & Engineering officer draag je bij aan de implementatie van geavanceerde farmaceutische systemen en zorg je ervoor dat toestellen en processen aantoonbaar gevalideerd zijn en voldoen aan de geldende GMP-richtlijnen en kwaliteitsvereisten, met bijzondere aandacht voor de steriele afdelingen. Daarbij werk je nauw samen met productie, kwaliteitsafdelingen en laboratoria. Je combineert technische expertise met een pragmatische aanpak op de werkvloer. Dankzij jouw bijdrage verlopen validaties efficiënt, compliant en betrouwbaar. Je taken omvatten onder andere:

  • Implementatie van geavanceerde farmaceutische systemen
  • Opstellen van validatieprotocollen, uitvoeren van validatietesten, opvolging van de resultaten en opstellen van validatierapporten op gebied van toestelvalidatie en -requalificatie
  • Periodieke review van validatie van processen, cleaning of equipment/facilities (PSQR)
  • Voorstellen maken ter verbetering van processen en meewerken aan het structureel oplossen van operationele problemen
  • Opvolgen en aflezen van mediafills, evenals rapportage
  • Opstellen en updaten van SOP’s
  • Ijking en verificatie van toestellen
  • Opvolgen en uitvoeren van CAPA’s afkomstig uit interne of externe inspecties
  • Uitvoeren van risico-analyses

Bezit jij deze talenten?

  • Sterk analytisch inzicht en oog voor detail
  • Gestructureerd, kwaliteitsgericht en administratief nauwkeurig
  • Goede communicatieve vaardigheden in Nederlands en Engels
  • Je bent goed in staat je eigen werk te organiseren en beschikt over goede communicatie skills
  • Je bent positief, pragmatisch en flexibel ingesteld, een zeldzame keer weekendwerk schrikt je niet af

Match jij met de gevraagde opleiding en ervaring?

  • Master in de industriële wetenschappen
  • 3 jaar werkervaring in de farmaceutische industrie
  • Je kan vlot werken met MS Word, Excel & Outlook
  • Kennis of ervaring met geautomatiseerde systemen (computer system validation, data integrity) is een pluspunt
  • Je hebt een uitstekende kennis van het Nederlands en Engels in woord en geschrift
  • Je bent niet allergisch aan penicillines of penicilline derivaten

Posting text belongs to the employer. Removal requests: contact us.

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