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Qualified Professional

4 weken geleden

Amsterdam, Noord-Holland, Nederland Morgan Green Voltijd

Beschrijving

Voor een farmaceutisch bedrijf in de regio Amsterdam ben ik op zoek naar een senior Quality specialist die tevens kennis en ervaring heeft als Qualified Person (QP). Dit bedrijf is actief in diverse aspecten van de farmaceutische industrie. In deze functie zal je zowel bezig zijn met kwaliteit en QP taken.

Functieomschrijving

Je voert, samen met het team, taken uit binnen de kwaliteit afdeling, daarnaast voer je tevens QP taken uit.

Verantwoordelijkheden

  • Ontwikkelen en implementeren van procedures en processen om ervoor te zorgen dat alle producten voldoen aan de kwaliteitsnormen (EMA, ICH, GxP, ISO9001)
  • Onderhouden van het kwaliteitsmanagementsysteem (QMS) met betrekking tot SOP's, deviaties, CAPA's en andere belangrijke documentatie.
  • Coördineren van interne audits en externe inspecties, en ervoor zorgen dat eventuele bevindingen snel en effectief worden opgelost
  • Zorgen voor de kwalificatie van leveranciers en klanten en het opstellen en bijhouden van kwaliteitsovereenkomsten
  • Zorgdragen voor de vrijgave van producten die voldoen aan alle kwaliteits- en regelgevingseisen
  • Initiëren van verbeterprojecten gericht op het verhogen van de kwaliteit en het optimaliseren van processen
  • Samen met je collega zorgen dat farmaceutische producten worden geproduceerd en verpakt in overeenstemming met de geldende GMP-regelgeving, de registratiedossiers en overige relevante wet- en regelgeving, en op basis van deze beoordeling de producten vrijgeven en certificeren.

Functie-eisen

  • HBO of wo opleiding in een wetenschappelijk vakgebied zoals Farmacie, Chemie of Life Sciences
  • Minimaal 5 jaar ervaring in een vergelijkbare rol binnen de farmaceutische industrie
  • Kennis en ervaring met taken van een Qualified Person (QP)
  • Uitgebreide kennis van GMP en relevante regelgeving binnen de farmaceutische sector
  • Beheersing van de Nederlandse en Engelse taal in woord en geschrift
  • Sterke persoonlijke eigenschappen; communicatief, teamspeler, zelfstandig, doelgericht, analytisch, resultaat gedreven, besluitvaardig, accuratesse, behulpzaam, ambitieus, daadkrachtig.

Bedrijfsprofiel:

Dit innovatieve bedrijf, gevestigd in Nederland, is een toonaangevende speler in de farmaceutische sector. Met een sterke focus op kwaliteit en naleving van regelgeving biedt het een dynamische werkomgeving waar teamwork en continuous improvement centraal staan.

Aanbod

  • Een uitdagende rol met groeimogelijkheden
  • Een marktconform salaris, afhankelijk van ervaring en kennis.
  • Flexibele werktijden
  • Een hecht team en een werkomgeving waar innovatie en samenwerking centraal staan

Reageer nu

Ben je geïnteresseerd in deze functie of ken je iemand die dat is? Neem dan contact op met Gabi Stolvoort via 030 200 3408 voor meer informatie of om direct te solliciteren.