QA Manager Operation

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Omrix Bio pharmaceuticals is seeking for a QA Manager Operation – for our Tel Hashomer site

JOB Description:

Responsible of plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates.

Duties & Responsibilities:

  • Establishes and maintains quality assurance programs, procedures, and controls. Ensures that performance and quality of products conform to established company and regulatory standards.
  • Responsibilities over quality issues at Production.
  • Responsibilities over QA batch release activities.
  • Supervise the work of team members regarding compiling and creating the documentation that accompanies batch release.
  • Overall responsibility for quality aspects of the facility, systems, equipment, validation, engineering and maintenance aspects.
  • Review and Approval of SOP’s, worksheets and forms related to products and processes.
  • Supervise the team in conducting relevant deviation and complaint investigations if needed.
  • Review and approve change controls, NCs (nonconformances) and CAPAs (corrective and preventive actions), as applicable.
  • Generate and review completeness of documents such as: procedures, protocols, risk management and validation.
  • Involve in preparation of annual review for product, water system, OFA system, HVAC system.
  • Support quality systems issues (CAPA’s, Non-Conformances and changes) related to Facility, systems, equipment, Laboratory, existing processes and developments of new processes. Participate in quality investigation including performing risk evaluation and product impact assessments
  • Support audits preparation (internal & external) and Participate in external audit with back room / front room role
  • Ensure compliance with Omrix and JNJ quality systems requirements
  • Training and development of team members


Reports to Senior QA Manager

Job Requirements:

  • BS degree in Business, Life Science, Physical Science, Engineering or another related field required.
  • Minimum of 4 years of experience in compliance or quality in a regulated (FDA) environment.
  • Experience in people management
  • Experience in bio pharmaceutical manufacturing is required, experience with combination products is preferred.

אומריקס הינה חברה ביו-טכנולוגית המייצרת ומפתחת מוצרים מצילי חיים ב- 2 תחומים: ביוכירורגיה וחיסונים פאסיביים. החברה נוסדה ב 1995 ומתמחה בפיתוח וייצור של מוצרים ביוטכנולוגיים מתקדמים מפלסמה אנושית. אומריקס מועסקים מעל 500 עובדים בישראל, בשלושה אתרים מרכזיים: תל השומר, הר החוצבים ירושלים ונס ציונה.

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