עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לחפש לבד בין מאות מודעות – תנו ל-Jobify לנתח את קורות החיים שלכם ולהציג לכם רק הזדמנויות שבאמת שוות את הזמן שלכם מתוך מאגר המשרות הגדול בישראל.
השימוש חינם, ללא עלות וללא הגבלה.
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Job description:
Responsibilities:
- Ensure computer systems comply with applicable regulations and standards throughout their full lifecycle, including implementation, upgrades, and ongoing operation.
- Plan, execute, and maintain Computer System Validation (CSV) activities in accordance with industry best practices.
- Execute CSV activities in compliance with regulatory requirements such as GxP, FDA 21 CFR Part 11, and EU GMP Annex 11.
- Participate in system lifecycle activities including implementation, upgrades, migrations, and system decommissioning.
- Prepare, review, and maintain validation documentation, including implementation, upgrades, migrations, and decommissioning.
- Prepare and review validation documentation including:Validation PlansUser Requirements Specifications (URS)Risk Assessments (e.g., GAMP 5 based).
- Support risk-based validation approaches and leverage supplier documentation when applicable.
- Perform and support testing activities, including deviation handling and proper documentation.
- Collaborate closely with IT, Quality Assurance, business stakeholders, and external vendors to resolve validation-related issues.
- Maintain validation status during system operation through change control processes and periodic reviews.
Profile description:
Requirements:
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
- 2–5 years of hands-on experience in Computer System Validation within regulated industries
- Practical knowledge of GxP regulations and guidelines including:FDA 21 CFR Part 11EU GMP Annex 11GAMP 5
- Familiarity with risk-based validation methodologies
- Strong documentation skills with high attention to detail
- Ability to work independently as well as in cross-functional teams
- Good written and verbal communication skills in English
We offer:
Why should you join us?
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Grow your career in a stable, innovative environment
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Collaborate closely with clients to deliver smart, high-quality solutions
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Make an impact in a dynamic, learning-driven environment
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Be part of a human, value-driven organization that cares
במקום לחפש לבד בין מאות מודעות – תנו ל-Jobify לנתח את קורות החיים שלכם ולהציג לכם רק הזדמנויות שבאמת שוות את הזמן שלכם מתוך מאגר המשרות הגדול בישראל.
השימוש חינם, ללא עלות וללא הגבלה.
נתניה
