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Open nowFirst seen 4 days ago

Compliance Engineer Pharma (Freelance kan)

EngiFlex115 open roles

Where
Geel, Belgium
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Your applicationOpen nowCompliance Engineer Pharma (Freelance kan)EngiFlex · Geel, Belgium

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

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

  4. CV RocketApplied on EngiFlex's own form.

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. EngiFlex postings stay open a median of 2 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: first seen 4 days ago

EngiFlex median: 2 days open

The posting

Functieomschrijving

Jouw rol als Compliance Engineer Heb je een sterke basis in GMP-compliance en een technische achtergrond in engineering of qualification? In deze functie maak je deel uit van het Reliability & Support team binnen Engineering & Maintenance. Je verbindt kwaliteit, engineering, maintenance en qualification en bent het centrale aanspreekpunt voor compliance-gerelateerde vragen. Daarbij zorg je mee dat processen voldoen aan de geldende farmaceutische richtlijnen en ondersteun je een correcte beheersing van risico's en kwaliteitsstandaarden.

Je verantwoordelijkheden

  • Acties binnen Veeva QMS beheren en nauwgezet opvolgen.
  • Root cause investigations coördineren bij technische afwijkingen.
  • Change controls opstellen en beheren in samenwerking met verschillende stakeholders.
  • CAPA-plannen uitwerken en de uitvoering van acties opvolgen.
  • Periodieke reviews van technische documentatie bewaken.
  • Engineering- en maintenance-teams adviseren over compliancevraagstukken.
  • GMP-vereisten vertalen naar werkbare technische oplossingen.
  • Werken binnen de relevante richtlijnen en kwaliteitskaders, waaronder Eudralex, Annex 1, ICH en ISPE.

📝 Jouw profiel

Je werkt zelfstandig, communiceert vlot met uiteenlopende stakeholders en analyseert complexe situaties op een heldere manier. In multidisciplinaire projecten bewaar je het overzicht en kom je via een pragmatische aanpak tot gedragen oplossingen, zonder in te boeten op kwaliteitseisen.

Wat breng je mee?

  • Een bachelor- of masterdiploma in een technische of wetenschappelijke richting.
  • 5 tot 10 jaar ervaring binnen pharma, engineering of qualification.
  • Aantoonbare ervaring met GMP-compliance en kwaliteitsprocessen.
  • Ervaring met Veeva QMS, deviations, CAPA en change controls.
  • Kennis van Eudralex, Annex 1, ICH en relevante ISPE-richtlijnen.

💼 Aanbod

Je zal deel uitmaken van een groeiende KMO met ruimte voor initiatief en persoonlijke ontwikkeling. Wij zorgen ervoor dat je in een uitdagende maar aangename werkomgeving terecht komt met leuke collega's. Samen met jou stippelen we een carriereplan uit, met aandacht en budget voor bijkomende opleidingingen / certificaties. Je kan rekenen op een motiverend salaris, aangevuld met extralegale voordelen, inclusief bedrijfswagen (of alternatieve vergoeding). (Freelance is ook mogelijk)

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