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Open nowFirst seen 3 days ago

Data Integrity Specialist Farma

EngiFlex113 open roles

Where
Geel, Belgium
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Your applicationOpen nowData Integrity Specialist FarmaEngiFlex · Geel, Belgium

  1. YouYes, apply to this one.

  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.

12.1% 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. 12.1%7 days
  4. 19.1%14 days
  5. 35.6%30 days
  6. 52.7%60 days
This job: first seen 3 days ago

EngiFlex median: 2 days open

The posting

Functieomschrijving

Jouw rol als Data Integrity Consultant In deze functie werk je binnen een hoogtechnologische farmaceutische omgeving in Geel. Je ondersteunt een Data Integrity-programma binnen Manufacturing en QC en onderzoekt de betrouwbaarheid, volledigheid en traceerbaarheid van gegevens. Daarbij stem je af met subject matter experts en een ervaren projectleider die je begeleidt tijdens de verschillende assessments. Met je analytische aanpak breng je risico's en verbeterkansen in kaart en draag je bij aan de kwaliteit en compliance van kritische systemen en apparatuur.

Je verantwoordelijkheden

  • Uitvoeren van GAP-assessments voor GxP-systemen en apparatuur
  • Opstellen en beoordelen van data flow mappings
  • Uitwerken van Data Integrity risk assessments volgens een vast protocol
  • Controleren van datatransfers en de betrouwbaarheid van equipment interfaces
  • Evalueren van audit trails en de traceerbaarheid van data
  • Beoordelen van toegangsbeheer en gebruikersrechten binnen applicaties
  • Vaststellen van tekortkomingen en formuleren van remediatieacties

📝 Jouw profiel

Je werkt nauwkeurig en gestructureerd binnen vastgelegde procedures. Je analyseert vlot de samenhang tussen systemen, processen en risico's en communiceert helder met verschillende stakeholders in een cross-functionele omgeving.

Hard skills

  • Je hebt een bachelor- of masterdiploma in een wetenschappelijke of technische richting.
  • Je hebt 1 tot 3 jaar ervaring in een GxP-gereguleerde omgeving.
  • Je hebt ervaring binnen farmaceutische Manufacturing en/of QC-omgevingen.
  • Je hebt een grondige kennis van Data Integrity en ALCOA+ of ALCOA++-principes.
  • Je bent vertrouwd met risk management en risk-based approaches, zoals ICH Q9.

💼 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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