Subject Matter Expert

4 weeks ago

Stockholm, Stockholm, Sweden Randstad Full time

Som konsult på Randstad Life Sciences är vi din arbetsgivare, men du har din dagliga arbetsplats hos en av våra kunder. Din konsultchef finns alltid nära till hands, både under och mellan uppdrag, för att hjälpa dig att utveckla din karriär i den riktning du drömmer om.

Som konsult hos oss får du en konkurrenskraftig lön, förmåner och kollektivavtalade villkor. Vi är lyhörda för dina önskemål gällande uppdrag och arbetsuppgifter och med vår breda kundportfölj i Mälardalen kommer vi tillsammans att anpassa din fortsatta karriär efter din kompetens, erfarenhet och ambition.

På Randstad Life Sciences har vi ett erbjudande som innebär att du har möjlighet att utveckla din kompetens och/eller ta extra ledighet efter att du varit hos oss ett tag.

Du kommer att ingå i ett större konsultteam inom Life Sciences och få möjlighet att bredda ditt nätverk och få värdefull erfarenhet från olika arbetsplatser.

Som SME Sterility Assurance Specialist spelar du en central roll i att säkerställa högsta kvalitet på företagets medicinska produkter. Du kommer att arbeta nära produktionen, QC och andra team inom Quality in Operation (QiO). Dina huvudsakliga ansvarsområden inkluderar mikrobiologiska avvikelseutredningar, agerande som Subject Matter Expert (SME) under inspektioner samt att delta i riskanalyser och trendanalys av resultat inom ditt ansvarsområde. Sektionen är ansvarig för att säkerställa kvaliteten på företagets mediesystem och mediefyllning, övervaka avdelningens kvalitetsarbete inom aseptisk tillverkning och hantera mikrobiologiska avvikelser. Man bör därför känna sig mycket trygg i arbete med aseptisk tillverkning, GMP och ha god kunskap inom mikrobiologi.

Om du känner att du har den erfarenhet och expertis som krävs för att bli en framgångsrik SME Sterility Assurance Specialist, skicka in din ansökan idag

Vi ser fram emot att välkomna en passionerad och kvalificerad individ till vårt team

ansvarsområden

  • Ledning av mikrobiologiska avvikelseutredningar och återkoppling till relevanta parter.
  • Stöd till befintlig produktion genom mikrobiologisk kompetens.
  • Deltagande i interna och externa inspektioner.
  • Utbildning och certifiering av produktionspersonal.
  • Säkring av aseptiska arbetsmetoder.

erfarenhet

Senior

kvalifikationer

  • Universitets- eller högskoleutbildning inom naturvetenskap eller bioteknik.
  • Erfarenhet inom mikrobiologi och aseptisk tillverkning.
  • Djupa kunskaper inom GMP och kvalitetssäkring/avvikelseutredningar.
  • Flytande i svenska och engelska.

Meriterande kvalifikationer:

  • Erfarenhet av aseptisk tillverkning av biologiska läkemedel.
  • Kunskap om proteinrening och processutveckling.
  • Erfarenhet av avvikelseutredning och mediasystem såsom WFI och gaser.

utbildning

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