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Quality Assurance Specialist till Cellcolabs

1 month ago

Stockholm, Stockholm, Sweden Wrknest Full time

Omvärlden av kvalitetsarbete

Cellcolabs är ett innovativt företag som tillverkar högkvalitativa mesenkymala stromaceller (MSCs) enligt strikta GMP-standarder. Deras produkter används inom banbrytande forskning för pre-kliniska och kliniska prövningar med potential att behandla kroniska sjukdomar.

Ditt ansvar

I rollen som Quality Assurance Specialist kommer du att vara en del av QA-teamet där ditt ansvar är att säkerställa kvaliteten för reguljär produktion av mesenkymala stamceller samt förbättra Cellcolabs QMS (quality management system).

Arbetsuppgifter

  • Säkerställa att produktionsverksamheten uppfyller kraven i relevanta standarder
  • Initiera och utfärda instruktioner
  • Delta i myndighetsinspektioner
  • Delta i riskbedömningar inom olika områden
  • Frisläppning av intermediat och slutprodukt
  • Driva och följa upp utredningar på avvikelser och ändringar samt implementera åtgärder
  • Aktivt bidra till organisationens utveckling

Krav

  • Högskole- eller universitetsexamen inom ett naturvetenskapligt ämne
  • Kunskap inom regelverk som GMP (helst även GDP)
  • Erfarenhet av självständigt QA-arbete
  • Goda kunskaper i svenska och engelska i tal och skrift

Meriterande

  • Erfarenhet av cellodling
  • Erfarenhet av metodvalideringar på QC ur ett QA perspektiv

Företaget

Cellcolabs grundades 2021 för att möta bristen på GMP-tillverkade stamceller för både kliniska prövningar och forskning. Med en gedigen grund i över 25 års forskning vid Karolinska Institutet, ledd av Professor Katarina Le Blanc, och med stöd från sina samarbetspartners, strävar Cellcolabs efter att bli ledande inom stamcellsproduktion.