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Supplier Quality Lead

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Omrix, a Bio-pharmaceutical company, is seeking a Supplier Quality Lead for our Tel-Hashomer site

This position will be responsible for the approval planning, execution, and documentation of the qualification and monitoring for suppliers and/or external manufacturers who input into the Ethicon Bio-surgery Supply Chain for the manufacture of blood product Intermediates, APIs, or drug products.

Providing Quality and Compliance oversight by ensuring quality standards are achieved and maintained at our Suppliers and External Manufacturers to meet J&J requirements and for inclusion on MD Global Biologic Approved Supplier List

This oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review and approval functions (such as Change Control, Deviation Handling), compliance audit activities, creation and management of risk mitigation plans for suppliers and external manufacturers.

This position requires the ability of building collaboration and teamwork across the local and global Ethicon Bio-surgery organization, and it interfaces Ethicon Bio-surgery Supplier Quality with the quality unit of suppliers and external manufacturers.

This position reporting to Supplier Quality Manager ETH Bio-surgery.

 

ESSENTIAL FUNCTIONS

Oversees compliance of existing supplier base and executes upon Supplier Quality Systems requirements assuring adequate controls over sourced goods and services. Effects and permanently maintains inspection readiness at third-party manufacturers and material-suppliers. Supporting of third-party manufacturers and suppliers during regulatory inspections and audits and during the development of corrective action plans.

Surveillance on the quality and compliance status for all suppliers and/or external manufacturers of raw materials, packaging materials, intermediates, excipients, APIs and service providers.

  • Performing audits at suppliers and external manufacturers
  • Management of Change related to supplier and/or external manufacturers
  • Assessment of deviations, corrective and preventative actions, and complaints concerning suppliers and external manufacturers
  • Provision of all information needed for the release/reject of suppliers.
  • Establishment and periodic review of Quality Agreements
  • Initial assessment and qualification of suppliers and external manufacturers for new product introductions, and establishment of initial Qualification Statements
  • Periodic performance measurement for suppliers and external manufacturers
  • Help in preparing external manufacturers for and support during health authority inspections
  • Supplier Quality representative and subject matter expert (SME) during regulatory audits at Ethicon Bio-surgery sites

Qualifications

  • A Bachelor’s Degree is required; a master degree is preferred;
  • A minimum of 5 years’ working experience in MD/biological industry, commercial manufacturing and/or R&D environment;
  • Experience in Quality Assurance, Quality Control and/or Compliance; previous experience in a Supplier Quality role is strongly preferred
  • Having the ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues;

·  Excellent interpersonal, written, oral and presentation skills (English).

*Resumes are to be sent in English only.

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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