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Quality Documentatie Officer

3 maanden geleden

Amsterdam, Noord-Holland, Nederland CheckMark Labrecruitment Voltijd
Bedrijfsomschrijving

Onze opdrachtgever in Amsterdam is een internationaal farmaceutisch bedrijf dat zeer actief is op het gebied van ontwikkeling van nieuwe medicijnen en nieuwe technieken om de gezondheid te bevorderen en te onderhouden. In deze rol zul je deel worden van het Quality service team wat het internationale Global Stability en Global Compendia team ondersteunt. In dit team ligt de focus op de tijdige levering van documentatie voor regelgevingsdoeleinden, statistische evaluatie van statistische gegevens en het tijdig informeren van EPD-sites over relevante compendia-wijzigingen.

Functieomschrijving

Als Quality Documentatie Officer wordt je verantwoordelijk voor het beheer van het Global Documentatie Management systeem. Daarbij sta je op wereldwijd niveau in contact met diverse afdelingen (zowel QA, als non-QA) binnen de organisatie welke je ondersteunt op het gebied van documentatieverwerking in het Electronic Document Management System. Je takenpakket zal bestaan uit o.a.:

  • Beheer van het Documentatie Management Systeem inclusief ervoor zorgen dat problemen in het systeem tijdig opgelost worden
  • Onderhoud en controle van quality documenten (procedures, protocollen, lab records, (audit-)rapportages, etc.) voor global en regionale afdelingen
  • Opvolging geven aan verzoeken voor het aanmaken of wijzigen van quality documenten, en de verwerking in het Global Documentatie Management systeem
  • Waarborgen van documentatie compliance volgens bedrijfs- en global kwaliteitssysteem- normen
  • Begeleiden en assisteren op het gebied van documentatie management- en change control- processen en systemen
Functie-eisen

Voor de functie van Quality Documentatie Officer zoeken we naar een pro-actieve HBO kandidaat die zich herkent in het volgende profiel:

  • HBO opleiding in Analytische Chemie, Biologie, Microbiologie of andere relevante technische/wetenschappelijke richting
  • Je neemt 1-3 jaar relevante ervaring mee op het gebied van GMP/GDP-documentatie en/of change control
  • Ervaring in het werken met een Electronic Document Management System is een pré
  • Binnen deze functie zul je geen werk gaan uitvoeren op het laboratorium
  • Als persoon ben je gedreven, pro-actief, flexibel en ben je een teamplayer
  • Je spreekt en schrijft vloeiend Nederlands en Engels
Arbeidsvoorwaarden
  • Lange termijn dienstverband, waarbij je start met een jaarcontract op basis van detachering via CheckMark
  • Salarisindicatie van €3000,- tot €4200,- bruto per maand o.b.v. fulltime
  • Fulltime dienstverband, waarbij 32 uur/week bespreekbaar is
  • Dagdienst
Sollicitatieprocedure

Neem voor meer informatie contact op met Jurjen Wilschut: //
Vacaturenummer: 8275