Yossi Sabov
Quality Assurance Audits Validation And IT Manager@ Gamida Cell Ltd.
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Yossi Sabov is a highly skilled professional with 16.9 years of experience in validation. Based in Israel, she has expertise in thermal validation, tanks, pumps, and QC equipment. Yossi has worked at Gamida Cell Ltd. in various roles, including QA Validation Manager and Process Engineer. She is proficient in writing, implementing, and approval of validation documents, risk assessment, and performance audits. Yossi is also experienced in professional consulting in equipment and utilities deviations during routine production.
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Emails and Phone Numbers

@gamida-cell.com
@gamida-cell.com
@gmail.com
@kamada.com
+1 212362****
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About

1. Validation expertise: - Thermal validation - Tanks SIP, Autoclaves (program, load development and performance) -FEDEGARI and TUTTNAUER, Ovens, Lyophilization, QC equipment (Incubators, Refrigirators, Freezers). -Tanks mixing - solution homogeneity, pasteurization. - Thermal validation equipment: Validator 2000 system (Kaye),TempTale, DATATRACE. - Calibaration. - Shipping validation (GDP). 2. Experienced with writing, implementing and approval of: Validation documents: Urs, DQ, IQ, OQ, PQ. Change Control. CAPA plan. Risk assessment/management. P&ID's. 3. Performance of audits (internal and supplier audit). 4. Presenting validation files during regulatory audits (e.g. FDA, Israeli health ministry ...). 5. Validation deviation management (opening, analysis and approval) and professional consulting in equipment and utilities deviations occurred during routine production. 6. Accompanying equipment and utilities projects.

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Work Experience

673 Boylston St, Boston, Massachusetts, 02116, US

Biotechnology Research

114
Phone
+1 6173151530
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Yossi Sabov's Professional Milestones

  • Quality Assurance Validation Manager (2021-04-01~): Implementing robust validation processes to drive product quality and ensure compliance with safety protocols.
  • Quality Engineer (validation) (2006-12-01~2010-05-01): Conducted thorough validations to ensure reliability and compliance with regulatory standards.
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