Compliance Specialist

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Omrix is seeking a Compliance Specialist for our Ness-Ziona site.

The Compliance Specialist is primarily responsible for providing regulatory technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures. This position will execute and maintain the Internal Audit program, support External Audits, and Audit Readiness, and ensure ongoing effectiveness of these quality systems.


 Major Duties and Responsibilities

Primary responsibility is to establish, evaluate, execute, and maintain the internal audit schedule and ensure that activities are carried out on time

Support all Omrix manufacturing sites to be inspection ready always and to alert senior management to potential quality system compliance issues in time to mitigate or prevent.

Know emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements in the internal audit program.

Provides compliance training to different functions within the organization as applicable and evaluates internal auditors as applicable


Required Knowledge, Skills and Abilities

  • 2 – 5 years related experience in Quality, Compliance or Regulatory Affairs
  • Maintains the internal audit schedule and conducts internal audit
  • Participates in external audits and support Omrix to be audit ready always
  • Participates in identifying issues and determining corrective actions in relation to applicable regulations, standards and J & J requirements
  • Working knowledge of Pharmaceutical/Biological and Medical Device applicable Standards and Regulations is a required
  • Excellent communication skills,
  • Strong collaboration and influence management skills
  • Accountability
  • High tolerance for ambiguity in a complex environment
  • Ability to make the complex clear and easily understood by others
  • Able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas
  • Ability to build partnerships both internally and externally

*Resumes are to be sent in English.

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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