Quality Assurance Specialist Life Science
17 hours ago
Du kommer att arbeta i ett unikt team där vår passion och branschkunskap kombineras med en varm gemenskap som värnar om varje individ. Vi är certifierat Great Place To Work-företag och placerar oss bland de bästa arbetsgivarna i Sverige.
Rollen:
Just nu söker vi en erfaren och engagerad Seniorkonsult QA för datoriserade system, som blir en del av vårt affärsområde Compliance och enheten Quality Management. Med vår djupa expertis inom projektledning, kvalitetssäkring och valideringsledning, hjälper vi våra kunder att genomföra viktiga verksamhetsförändringar.
Med din expertis inom QA för datoriserade system kommer du att vara en central spelare i rådgivande roller, både som konsult i kundens organisation och i projektleveranser. Du kommer att få utmanas och ta dig an spännande uppdrag och projekt inom Life Science där din expertis verkligen gör skillnad.
Exempel på ansvarsområden:
- Säkerställa att regulatoriska krav och standarder enligt GMP/GxP efterlevs.
- Genomföra riskhantering och kvalitetssäkring inom investerings- och/eller förbättringsprojekt.
- Rådgivning och stöd i kundprojekt inom QA datoriserade system och IT.
- Kvalitetsledning inom datoriserade system och CSV.
- Granska och godkänna dokumentation och processer relaterade till datoriserade system.
- Utveckla och uppdatera kvalitetssystem (QMS) med fokus på datoriserade system.
- Utföra leverantörsbedömningar och delta vid eller leda inspektioner/audits med fokus på kvalitetssäkring av system och GAMP.
- Agera utbildare och mentor inom kvalitetsrelaterade ämnen.
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