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Open nowPosted 4 days ago

Manufacturing Validation Lead | Pharma | Geel

EURES job mobility portal215,277 open roles

Where
Turnhout, Belgium
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Your applicationOpen nowManufacturing Validation Lead | Pharma | GeelEURES job mobility portal · Turnhout, 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.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 4 days ago

The posting

Jouw baan als Manufacturing Validation Lead

Wil jij mee instaan voor de kwaliteit en compliance van validatieactiviteiten binnen een internationale farmaceutische omgeving? Als Manufacturing Validation Lead begeleid je validatie- en kwalificatieactiviteiten voor zowel transportprocessen als producten die geproduceerd worden door externe manufacturing partners. Je bent een belangrijke kwaliteitsstem binnen projecten en ondersteunt teams bij complexe validatievraagstukken. Daarbij werk je samen met CMO's, kwaliteitsafdelingen en internationale stakeholders. Dankzij jouw expertise zorg je ervoor dat processen voldoen aan de hoogste GMP- en GDP-standaarden en klaar zijn voor audits, inspecties en registraties.

Gelukkig kunnen we op jou rekenen bij het:

  • Opstellen, reviewen en goedkeuren van validatiedocumentatie
  • Beoordelen van kwalificatie- en validatiedossiers van CMO's
  • Ondersteunen van proces- en transportvalidaties tijdens studiefases
  • Evalueren van wijzigingen, afwijkingen, audits en CAPA's
  • Goedkeuren van CPV-rapporten en bijdragen aan APQR-reviews
  • Optreden als validation SME tijdens audits en inspecties
  • Bewaken van GMP-, GDP- en wereldwijde kwaliteitsvereisten

Je werkt gestructureerd en behoudt het overzicht over meerdere projecten tegelijk. Dankzij je sterke communicatieve vaardigheden stem je vlot af met internationale stakeholders en externe partners. Je neemt zelfstandige beslissingen en weet risico's tijdig te identificeren en te beoordelen.

Hard skills

  • Bachelor of master in een wetenschappelijke richting
  • Minimaal 6 jaar ervaring binnen validatie of quality assurance
  • Ervaring binnen farmaceutische, biotech- of medical device omgevingen
  • Vlotte kennis van Engels, zowel mondeling als schriftelijk
  • Kennis van GMP, GDP, process validation, qualification en shipping validation
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