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QA-IT & CSV Lead

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Omrix Biopharmaceuticals is seeking a QA-IT & CSV Lead.

General Summary

The QA-IT & CSV Lead shall oversee all computer system validation activities across all Omrix and Nuchatel sites for business applications, QC laboratories, and production manufacturing systems. The QA-IT & CSV Lead manages a team that ensure all site priorities are resourced appropriately. This shall include oversight of the CSV requalification program as well as validation planning and resourcing for all Business Application lifecycle management projects. Ensures sites comply with procedures and regulations, as well as coaching validation engineers on validation skills.

 

Principal Duties and Responsibilities

  • Supervises the daily activities of the CSV Engineers. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Trains, plans, schedules and assigns work, appraises performance and resolves problems. Approves changes to documentation and processes.
  • Provides independent quality oversight, ensures compliance and technically appropriate cGMP oversight, and is approver of site validation activities/protocols/reports & SOPs as it relates for IT Business applications and computer system validations. Ensures the validated state is maintained throughout its lifecycle.
  • Provides input of validation requirements, resources, timelines and budget as part of thorough validation planning for all activities at the site. Partners cross-functionally to ensure validation planning is timely and appropriate for validation activities.
  • Develops, implements and maintains validation policies, procedures, templates and supports a culture of continuous improvement.
  • Adapts compliance tools and methodologies to the needs of the project.
  • Supervises validation approach to ensure continuous improvement consistent with established and evolving regulatory and company environment. Proactively assesses the impact of regulatory changes on the business and IT processes and advises management of the implications.
  • Provides guidance and oversees complex investigations to close out validation discrepancies / exceptional conditions. Participates in or leads resolution of compliance issues of varying complexity. Ensures appropriate resolution and documented justification.
  • Assesses and manages compliance risks, escalating to management as necessary.
  • Works with IT, QA, and business colleagues to ensure audit readiness and to prepare for internal and external audits.
  • Participates in regulatory audits as technical expert for CSV validation packages. Ensures validation activities are consistent with applicable regulatory requirements and appropriately conveyed to regulatory bodies via associated regulatory submissions or as required.
  • Participates in audits to explain compliance tools and methodologies, and identifies gaps in audit readiness.

 

  Education and/or Experience

  • At a minimum, a BA/BS degree (BS Engineering preferred) or equivalent in Science or Engineering is required.
  • Minimum 4 – 8 years’ experience, including broad validation experience in pharmaceuticals and combination products.
  • Experience mentoring and coaching junior engineers.
  • Project management experience required.
  • Experience participating and successfully collaborating in cross-functional project team environments.
  • Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives required.
  • Knowledge and experience with discrepancy investigations/validation deviations required.
  • Thorough knowledge of GMPs related to validations as well as FDA and EU regulatory requirements for biologics and combination products.
  • Strong collaboration, communication, presentation and influencing skills required. The ability to interact and gain the support of key stakeholders required

 

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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