Experience

Epitomee Medical

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• V&V manager

  • May 2022 - Present



Omrix Biosurgery Israel

• Israel
• Biotechnology Research
• 200 - 300 Employee

• Technical Lead

  • Jan 2018 - Jul 2022

  Technical process lead of drug performance, changes, improvements etc.

• Process Validation Engineer

  • Dec 2012 - Dec 2017

  Process Engineer; specialize in process validation activities, responsible for the implementation of new/modified product in commercial plant, which includes the creation, strategy and execution of process performance qualification/ process verification of plasma derived protein drugs.Leads process validation activities for all products, and focal point in terms of process validation policies and procedures in PFI plant; great understanding for the requirement as detailed in:• FDA - Process Validation: General Principles and Practices guide • EMEA – Annex 15: Qualification and ValidationExperience in performing technology Transfer from R&D to commercial plant and lead technical assessment, criticality assessment, risk assessment etc. to implementation a robust process that ensures meeting Quality attributes.Explore, plan, and executed any process related study/validation, to validate process parameters, Hold time, learn on drug sensitivities, process robustness, etc. according to all relevant FDA stages. Support RA with process change submission, updating applicable process submission modules, and provide answers for authorities review letters Investigate complex process related nonconformance/discrepancies, and take action for mitigation and process improvement as corrective action.Works to increases and analyze gained knowledge as part of CPV; and implements the gained knowledge for continuous improvement in terms of cost saving, increasing robustness and so on.Has a solid understanding of the principles of QA, R&D, Validation, Engineering, QC, Production, SC, RA and any department involved in the pharmaceutical drugs life cycle. As part of my position I have gained several awards following successful completion goals. Show less



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technological and Scientific Affairs (T&SA) Researcher

  • Feb 2010 - Dec 2012

  Technical project manager of sterile drugs (chemical and Biological), responsible to lead the execution of activities post development (stage one), within commercial scale plant (stage two). Start with pilot scale batches for stability through the various milestones until commercial PPQ batches and product launch. • Tech transfer from R&D to production, act as a receiver and as a transferer. •Plan, manage and execute process qualification related activities. •Lead scale up and risk assessment activities. •Multi discipline function coordination, communication and understanding. In addition, I lead and became the professional focal point of shipping qualification activities for all sterile products in Kfar-Saba plant. Throughout my working period I have received three recognition letters. Show less