Document Control
5 days ago
Document Control & Quality systems Associate
- חברה: גמידה סל בע"מ
- משרה:
Document Control & Quality systems Associate - מחלקה: Compliance, QMS & Field
- פונקציה: Quality
- מדווח ל: Senior Quality Compliance Manager
- משרה מלאה, 5 ימים בשבוע, On Site ממשרדי החברה בקריית גת
Gamida Cell is a leader in advanced cellular therapies and hematopoietic stem cell transplantation, with two FDA approved therapies, Omisirge (omidubicel-onlv) and APHEXDA (motixafortide). Omisirge is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy that is potentially curative for patients with hematologic malignancies. APHEXDA is a CXCR4 antagonist with long receptor occupancy indicated in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
תחומי אחריות:
בקרה על מחזור חיים של המסמכים המבוקרים בחברה, כגון:
תחזוקה של מודול מסמכים מבוקרים
עריכת מסמכים
בקרה ותחזוקה של תהליכי הפצה, תיעוד ואחסון רשומות איכות
- ה
שתתפות בתהליכי שיפור מתמיד במערכות האיכות - בקרה על מדדי KPI (מדדי מפתח להצלחה) עבור תהליכי איכות כגון: הדרכות ובקרת מסמכים
- תכנון ותחזוקה של תשתית המודולים במערכת אלקטרונית לניהול מערכת האיכות
- השתתפות בבנייה וביצוע של תוכניות הדרכות איכות
- תמיכה פעילה במבדקים של גופים רגולטוריים חיצוניים
דרישות:
- ניסיון מתקדם ואוריינטציה גבוהה בעבודה עם מערכות ממוחשבות - חובה
- ניסיון באדמיניסטרציה ומתן שירות - חובה
- Microsoft Office - ברמה גבוהה (Word)
- אנגלית - ברמה גבוהה (קריאה, דיבור, כתיבה)
- יכולת עבודה בצוות
- תואר ראשון - יתרון
-
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