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Open nowFirst seen 2 days ago

Manufacturing Validation Coördinator Pharma

EngiFlex121 open roles

Where
Geel, Belgium
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Your applicationOpen nowManufacturing Validation Coördinator PharmaEngiFlex · 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.

The reply lands in your private mailbox

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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 1 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 2 days ago

EngiFlex median: 1 days open

The posting

Functieomschrijving

Jouw rol als Manufacturing Validation Lead In deze functie bewaak je de kwaliteit en compliance van validatieactiviteiten binnen een internationale farmaceutische context. Je begeleidt validatie- en kwalificatieactiviteiten voor transportprocessen en producten die worden geproduceerd door externe manufacturing partners. Daarbij fungeer je als belangrijk aanspreekpunt voor kwaliteitsgerelateerde validatievragen en ondersteun je teams bij complexe dossiers.

Je werkt nauw samen met externe productiepartners, kwaliteitsafdelingen en internationale stakeholders. Met jouw expertise zorg je ervoor dat processen voldoen aan de geldende GMP- en GDP-vereisten en goed voorbereid zijn op audits, inspecties en registratietrajecten.

Je verantwoordelijkheden

  • Opstellen, beoordelen en goedkeuren van validatiedocumentatie
  • Evalueren van kwalificatie- en validatiedossiers van externe manufacturing partners
  • Ondersteunen van procesvalidaties, shipping validation en transportvalidaties tijdens studiefases
  • Beoordelen van wijzigingen, afwijkingen, audits en CAPA's
  • Goedkeuren van CPV-rapporten en bijdragen aan APQR-reviews
  • Optreden als validation SME tijdens audits en inspecties
  • Toezien op de naleving van GMP-, GDP- en bredere kwaliteitsvereisten

📝 Jouw profiel

Je werkt gestructureerd, behoudt het overzicht over meerdere projecten en communiceert vlot met internationale stakeholders en externe partners. Je neemt zelfstandig beslissingen en weet risico's tijdig te signaleren en correct te beoordelen.

Hard skills

  • Je hebt een bachelor- of masterdiploma in een wetenschappelijke richting
  • Je hebt minimaal 6 jaar ervaring binnen validatie of Quality Assurance
  • Je hebt ervaring in een farmaceutische, biotech- of medical device-omgeving
  • Je communiceert vlot in het Engels, zowel mondeling als schriftelijk
  • Je beschikt over kennis van GMP, GDP, process validation, qualification en shipping validation

💼 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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