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Open nowFirst seen 5 days ago

Senior Specialist IT Quality Compliance Pharma

EngiFlex117 open roles

Where
Geel, Belgium
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Your applicationOpen nowSenior Specialist IT Quality Compliance PharmaEngiFlex · Geel, Belgium

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

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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. 58.1%60 days
This job: first seen 5 days ago

EngiFlex median: 2 days open

The posting

Functieomschrijving

Jouw rol als Senior IT Quality Compliance Specialist

In deze functie bewaak je de kwaliteit en compliance van IT-systemen en digitale processen binnen een gereguleerde farmaceutische omgeving. Je zorgt ervoor dat systemen voldoen aan de geldende GMP-richtlijnen en kwaliteitsvereisten, en treedt op als aanspreekpunt voor validatie, compliance en inspectiegereedheid. Daarbij werk je nauw samen met kwaliteitsverantwoordelijken, systeemeigenaars en andere stakeholders.

Met jouw expertise help je IT-processen betrouwbaar, compliant en auditklaar te houden. Je draagt ook actief bij aan de verdere verbetering en uitwerking van processen en kwaliteitsdocumentatie.

Je verantwoordelijkheden omvatten onder meer:

  • Beheren van IT-compliance- en validatiedossiers over de volledige levenscyclus
  • Uitvoeren van risicoanalyses volgens GAMP 5 en ALCOA+-principes
  • Coördineren van change controls, inclusief impactanalyse en compliance review
  • Opvolgen van deviatiebeheer, CAPA-processen en documentatie
  • Ondersteunen van GxP-audits en inspecties als inhoudelijk aanspreekpunt
  • Opstellen en actualiseren van SOP's, procedures en werkinstructies
  • Monitoren van KPI's, periodieke reviews en andere compliance-activiteiten
  • Toepassen van relevante kwaliteits- en compliancekaders, waaronder 21 CFR Part 11, EU Annex 11, ICH Q10 en ALCOA

📝 Jouw profiel

Je werkt gestructureerd en nauwkeurig binnen een sterk gereguleerde context. Je analyseert complexe processen vlot en vertaalt die naar duidelijke procedures en kwaliteitsdocumentatie. Daarnaast communiceer je helder met verschillende betrokkenen en neem je verantwoordelijkheid op voor je dossiers.

Verder breng je mee:

  • Een bachelor- of masterdiploma in IT, Life Sciences of een verwante richting
  • Minstens 6 jaar ervaring binnen CSV, IT Quality of GxP-compliance
  • Grondige kennis van GAMP 5, 21 CFR Part 11, EU Annex 11 en ICH Q10
  • Ervaring met change control, CAPA, deviatiebeheer en validatieprocessen
  • Vlotte kennis van Nederlands en Engels
  • Kennis van GMP en ALCOA-principes

💼 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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