פרופיל תעסוקתי:

תואר ראשון דו-חוגי ביולוגיה ופסיכולוגיה בהדגש מדעי המוח
השכלה

דיפלומה
קורס עורכי מבדקים פנימיים-הרשות הלאומית להסמכת מעבדות.
קורס ביקורת פנימית-מערכות מידע-הרשות הלאומית להסמכת מעבדות.
יום עיון ISO/IEC 17025 מהדורה 2017-הרשות הלאומית להסמכת מעבדות.
קורס עקרונות ה OECD GLP-הרשות הלאומית להסמכת מעבדות.

שירות צבאי
2004 - 2008
Military Service
Ground Forces Officers' School (Bahad 1)
Israel Defense Forces.
2005-2008
 Battalion collecting station commander-in reserve (rank: Master sergeant).
 Acting master sergeant of brigade clinic (rank: Sergeant first class).
 Regimental medic - non-commissioned officer (rank: Staff sergeant).
50th Infantry Battalion, The Nahal Brigade.
Israel Defense Forces. 2004-2005
 Company medic.
 Platoon medic.
 Company medic qualification.
 Basic and advanced infantry training.
ניסיון תעסוקתי
Quality Assurance Associate.
Sterility Assurance and Microbiology Specialist.
Rekah Pharmaceutical Industries Ltd.
2020-2022
Quality Assurance Lead.
Vivox Ltd.
2022–2023
 Continual management of the existing, paper-based, quality system, while initiating, evaluating, acquiring, and
implementing a pre-validated cloud-based electronic QMS.
 Adopting a risk-based approach for QA and subsequent preparation and execution of an internal QA audits
program, accordingly.
 Implementing improvements in key processes such as data collection, documentation practices, record
management, data governance, information storage and archiving.
 Initiation and application of new QA tools, such as quality risk management (QRM), root cause analysis
(RCA), supplier qualification (SQ), and supplier quality management (SQM).
 Writing a thorough, structured yet gradual and clear plan for further quality improvements measures.
 Reviewing, revising, and updating the existing quality manual, standard operating procedures (SOPs). Such
as, documents control, change control, management review, deviations and non-conformities, CAPA,
handling of quality complaints. Writing new policy documents and SOP such as CSV and InfoSec, biosafety
and biosecurity policy documents to name a few.
 Reorganization of the personnel training process, including redevelopment of the curriculum to create a
comprehensive and uniform personnel qualification, introducing professional competency evaluations and
performance benchmarking, among others.
 Promotion of a new comprehensive animal health, care and welfare program, including contamination
control plan of the animal facility and animal health monitoring program.
 Contributing to the initial qualification and validation of the sterile drugs manufacturing facilities.
 Planning a comprehensive CCS and overseeing compliant execution. Ensuring periodic re-qualification of
critical areas, including aseptic process simulation (known as media fill).
 Ensuring adequate training and qualification of the personnel involved in aseptic processing and sterile drug
manufacturing. Emphasizing maintenance of personnel files with training and qualification records.
 Ensuring personnel compliance with the relevant procedures, including periodic evaluation of the employee
aseptic technique proficiency and overall GMP compliance. Professional supervision of twelve employees
across two departments.
 Ensuring adequate microbiological sampling of the sterile manufacturing facility and personnel, ensuring
appropriate documentation.
 Ensuring compliant environmental monitoring of non-viable particles, reviewing, and approving the
monitoring records from each manufacturing session.
 Assurance of ongoing tracing and compliant documentation of microbiological sampling and non-viable
particles monitoring results. Approval / performance of trend analysis before releasing any batch of a finished
product.
 QA overseeing of various pharmaceutical qualification and validation activities of sterile and non- sterile
products at the manufacturing site.
 Writing, reviewing, or approving relevant SOPs, validation plans and validation reports microbiological
specifications of raw materials, intermediates, and finished products.

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