Ilanit Burnstein Email and Phone Number
Ilanit Burnstein work email
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Ilanit Burnstein personal email
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Over 10 years experience in leading quality, according to ISO 9001, ISO 13485, ISO 17025, GMP (Annex 1), FDA, 21 CFR Part 11 and Annex 11 requirements.Experience in Pharma, Cell therapy, Medical Device and Medical Cannabis industries, as well as Hospitals and Academy.Strong background in microbiology and molecular biology (M.Sc). Ability to work under pressure and to deliver high results.Open minded, with the ability to self-train.Able to prioritize effectively, multi-task and achieve objectives on time.Skilled in strategic planning and implementation.Well-developed management and interpersonal skills.
Hylabs (Hy Laboratories Ltd)
View- Website:
- hylabs.co.il
- Employees:
- 27
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Chief Quality And Regulatory OfficerHylabs (Hy Laboratories Ltd) Mar 2023 - PresentRehovot, Central, Israel -
Director Of Quality And Regulatory AffairsHylabs (Hy Laboratories Ltd) Aug 2021 - Mar 2023ReẖOvot, Central, Israel -
Quality Unit ManagerHylabs (Hy Laboratories Ltd) Jul 2019 - Aug 2021ReẖOvot, Central, Israel> QA/QC Unit management.> Quality management according to ISO 9001, ISO 13485, ISO 17025, GMP (Annex 1), FDA requirements.> Computerized systems management according to 21 CFR Part 11, Annex 11.> Lead and management of quality in the company: - Products and services for the industries of Pharma, Cell therapy, Medical Device, Medical Cannabis, Health care and Academy. - Service Labs - Microbiology, Chemistry, Molecular and Cell Biology. - Outdoor services - Sampling services, Technical services. - Manufacturing - Microbiology products, Molecular kits. - Imported products.> Leading certification bodies' and regulatory audits (FDA, MOH, ISRAC, SII).> Leading customers' audits.> Implementing standards' updates in QMS.> Establishing QMS for new service laboratories.> Implementing new services.> Leading certifications for new services, new service laboratories, according to updated standards' revisions. > Leading projects, including renovation of clean room to meet ISO14644 and Annex1 requirements.> Leading organization developments.> Quality Control management. -
Qa ManagerHylabs (Hy Laboratories Ltd) Nov 2017 - Jul 2019ReẖOvot, Central, Israel> QA department manager.> Quality management according to ISO 9001, ISO 13485, ISO 17025, GMP (Annex 1), FDA requirements.> Computerized systems management according to 21 CFR Part 11, Annex 11.> Lead and management of quality in the company: - Products and services for the industries of Pharma, Cell therapy, Medical Device, Medical Cannabis, Health care and Academy. - Service Labs - Microbiology, Chemistry, Molecular and Cell Biology. - Outdoor services - Sampling services, Technical services. - Manufacturing - Microbiology products, Molecular kits. - Imported products.> Leading certification bodies' and regulatory audits (FDA, MOH, ISRAC, SII).> Leading customers' audits.> Implementing standards' updates in QMS.> Establishing QMS for new service laboratories.> Implementing new services.> Leading certifications for new services, new service laboratories, according to updated standards' revisions. > Leading projects.> Leading organization developments. -
Head Of Service Laboratories QaHylabs (Hy Laboratories Ltd) Aug 2012 - Nov 2017ReẖOvot, Central, Israel> Service Labs QA Management.> Quality assurance management according to ISO 9001, ISO 13485, ISO 17025, GMP, FDA requirements.> Lead and management of quality assurance in the service labs: - lab services for the industries of Pharma, Cell therapy, Medical Device, Hospitals and Academy. - Microbiology service lab, Molecular and Cell biology service lab, Chemistry service lab. - Interface with lab employees and managers for quality implementation. - Management and quality implementation of work in a clean room (according to Annex 1). - Integral part of customers, qualification bodies and regulatory audits. - Writing and implementation of working procedures. - Investigations handling (Deviations, Complains, OOS), including CAPA, effectiveness and final report. - Internal and suppliers' audits performance, including final report and follow up. - Management and implementation of Risk Analysis. - Change Control Management. - Documentation Control. - Approval of validations (internal and for customers) -
Senior Consaltant For Quality And RegulationAlagene Ltd. Mar 2022 - Present -
Qa Associate And Research ScientistRosetta Genomics Feb 2008 - May 2012> Work in ISO 9001, ISO 13485, GCP environment.> Writing and implementation of procedures and work methods.> Writing and management of change controls, CAPAs, deviations.> Internal Audit performance.> Management of laboratory equipment calibrations.> Management of laboratory notebooks.> Maintenance and organization of quality documents.> Laboratory experience in cDNA preparation, PCR, RT-PCR, In Situ Hybridization, Immunohistochemistry.
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Research ScientistWeizmann Institute Of Science 2005 - Feb 2008Laboratory experience in Molecular Biology, Immunohistochemistry and laboratory animals.
Ilanit Burnstein Education Details
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Medical Science -
Medical Laboratory Science
Frequently Asked Questions about Ilanit Burnstein
What company does Ilanit Burnstein work for?
Ilanit Burnstein works for Hylabs (Hy Laboratories Ltd)
What is Ilanit Burnstein's role at the current company?
Ilanit Burnstein's current role is Chief Quality and Regulatory Officer at Hy Laboratories Ltd. (hylabs).
What is Ilanit Burnstein's email address?
Ilanit Burnstein's email address is il****@****s.co.il
What schools did Ilanit Burnstein attend?
Ilanit Burnstein attended Tel Aviv University, Ben Gurion University.
Who are Ilanit Burnstein's colleagues?
Ilanit Burnstein's colleagues are Dana Godel, Tzvi Tzubery, Yael Pelez, Nataly Hen, Irina Kalchenko, Ilona Davidson, Mazor Kapri.
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