Quality Assurance Engineer with extensive experience in pharmaceutical, biopharmaceutical, and food manufacturing. Skilled in managing Non-Conformances, CAPAs, Change Controls, batch review, SOPs, Environmental Monitoring, and Material Review Boards. Actively involved in FDA, EMA, and Israeli MOH inspections, handling observations, rejects, and regulatory responses. Recognized for a strong work ethic, ability to manage complex processes, multitasking under pressure, organization, and excellent
Einav K.
- פתח תקווה, Israel
- Quality Engineer
- 9 שנים
לפני 6 ימים
- אנשי הקשר שלי
- בקשות חברות
- הוסף המלצה
- חסימה
- Download CV
סיכום קורות חיים
ניסיון תעסוקתי
Quality Assurance Specialist
Omrix Biopharmaceuticals Ltd (J&J Company)2019 - 2021
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Quality Assurance Specialist
Ahdut2017 - 2019
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[redacted]
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על מנת לצפות במידע נוסף על ניסיון התעסוקתי יש לחשוף את פרטי ההתקשרות של המעומד.
השכלה
אחר
| כללי
Ariel University
2013 - 2017
Quality Assurance Engineer | SciVac ltd Biotechnology. Worked in a GMP-regulated environment supporting the manufacturing of the Hepatitis B vaccine, with responsibility for a broad range of Quality Assurance activities. The role included being solely responsible for both oversight and direct execution of QA tasks across Production, Warehouse, and Visual Inspection departments and conducting validations.
אחר
| כללי
Ariel University
2017 - 2017
Worked in accordance with FDA, EMA, GDP, GMP, and ISO requirements. Responsibilities included managing Non-Conformances, CAPAs, and handling Change Controls, as well as creating and updating SOPs. Also, support of equipment and process validation activities, provided on-site support for manufacturing processes, oversaw the receipt and approval of raw materials, and was responsible for the Environmental Monitoring analysis.
אחר
| כללי
Sher Consulting & Training
2017 - 2017
אחר
| כללי
Estella
2012 - 2012
אחר
| כללי
Ben Gurion High School
2005 - 2008
מיומנויות
0
Quality Assurance
0
GMP
0
GDP
0
ISO
0
Environmental Monitoring
0
SOPs
0
CAPAs
0
Change controls
0
Batch Review
0
Multitasking
0
Interpersonal skills
0
Service-oriented
המלצות מקצועיות
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נשלחו (0)
לא נמצאו המלצות מקצועיות
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שפות
Hebrew |
ברמת שפת אם
English |
ברמה טובה