Senior Manager för Produktionsförberedelse
1 month ago
Är du intresserad av en mångfacetterad roll med många gränssnitt och stort ansvar för att hantera projekt inom en reglerad miljö?
Vi söker en expert inom projektledning för att gå med i vårt team för Produktionsförberedelse. Ditt huvudsakliga ansvar kommer att vara att leda och delta i projekt inom produktutveckling, produktuppdateringar, produktregistreringar och processutveckling.
Mer om tjänsten
Du kommer att arbeta både med introduktion av nya produkter och med uppdateringar av produkter och processer. Du kommer att ha ansvar för att leda överföringen av nya och uppdaterade produkter till regelbunden produktion med produktgranskningar. Arbetet inkluderar ansvar för produktgranskningar samt att vara involverad i att utveckla och förbättra processen för produktförberedelse. Du uppmuntras också att bidra till grupper och ditt eget arbetssätt för att ständigt förbättra och effektivisera för att säkerställa kvalitet och leverans av projekt och produkter.
Du kommer att leda eller delta i tvärfunktionella team med olika kompetenser beroende på projekten. Detta kan inkludera kollegor från produktion, regulatoriska frågor, kvalitetskontroll och forskning och utveckling, processvalidering och leveranskedja.
Hur når du dit?
Du arbetar för närvarande i en koordinerande roll eller som projektledare, kvalitetsansvarig, utvecklingschef, teknisk specialist eller liknande. Vi vill att du har en vetenskaplig eller teknisk högskoleutbildning. Erfarenhet av design och utveckling, designkontroll och designöverföring inom in-vitro-diagnostik eller andra reglerade aktiviteter inom medicinteknik/läkemedel/livsvetenskap är avgörande, liksom erfarenhet av projektledning.
Denna roll passar dig som har ett starkt fokus på kvalitet och dokumentation. Erfarenhet av MDSAP, ISO 13485, FDA QSR och liknande regulatoriska ramverk är viktigt. Kunskap om IVD-produkter är meriterande.
Du är en drivande problemlösare och kan självständigt leda. Du är en utmärkt samarbetspartner, som ger tydlig kommunikation och som är proaktiv i ditt arbetssätt. Som person tror vi att du är effektiv, flexibel, företagsam, har starka ledarskapsförmågor och en koordinerad syn. God kunskap om våra produkter och erfarenhet av våra produktionsflöden är starkt meriterande.
Du kan enkelt kommunicera på både svenska och engelska, både skriftligt och muntligt.
Vi värdesätter personliga egenskaper och motivationer högt.
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