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Open nowPosted 2 days ago

Batch Record Reviewer Farma

EURES job mobility portal594,927 open roles

Where
Turnhout, Belgium
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Your applicationOpen nowBatch Record Reviewer FarmaEURES job mobility portal · Turnhout, Belgium
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The clock on this job

Early applications get read.

10.5% of postings close within 7 days. Measured by our own scanner across the market. EURES job mobility portal postings stay open a median of 9 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.3%3 days
  3. 10.5%7 days
  4. 15.9%14 days
  5. 34.1%30 days
This job: posted 2 days ago

EURES job mobility portal median: 9 days open

The posting

Functieomschrijving

Voor een project in de farmaceutische sector in Geel zoeken we een Batch Record Reviewer. In deze functie vorm je de schakel tussen productie en kwaliteit en zorg je ervoor dat batchdocumentatie volledig, correct en in lijn met de geldende GMP-richtlijnen wordt verwerkt.

Met een kritische en nauwkeurige aanpak spoor je afwijkingen tijdig op en zorg je voor een correcte opvolging. Je werkt daarbij samen met QA, procesingenieurs, operatoren en productieverantwoordelijken om de productkwaliteit en een betrouwbare geneesmiddelenproductie te ondersteunen.

Jouw taken

  • Je beoordeelt batchdocumentatie na productie en reiniging.
  • Je analyseert en documenteert afwijkingen volgens GMP-procedures.
  • Je controleert en vervolledigt batchrecords en bijlagen.
  • Je keurt kritische en niet-kritische productieverslagen goed.
  • Je organiseert en archiveert batch- en reinigingsdocumentatie.
  • Je ondersteunt productiezones en beheert plantstock.
  • Je stemt af met QA, productie en engineering over documentatie, validatie en kwaliteitsopvolging.

Je werkt nauwkeurig en behoudt het overzicht wanneer meerdere dossiers tegelijk opgevolgd worden. Je denkt analytisch, legt snel verbanden en onderzoekt afwijkingen op een gestructureerde manier. Daarnaast communiceer je vlot met verschillende stakeholders en neem je verantwoordelijkheid voor de kwaliteit van je werk.

  • Je hebt een professionele bachelor in een wetenschappelijke richting, zoals chemie, biochemie, farmaceutische of biologische laboratoriumtechnologie.
  • Je hebt minstens 2 jaar ervaring binnen QA of kwaliteitscontrole in pharma of life sciences.
  • Je hebt ervaring met documentatie in een GMP-omgeving.
  • Je hebt kennis van productieprocessen, validatie en afwijkingsbeheer.
  • Je communiceert vlot in het Nederlands en Engels, zowel mondeling als schriftelijk.
  • Je werkt vlot met MS Office. Ervaring met SAP, MES of gelijkaardige systemen is een plus.
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