Alex Kazak, M.Sc.Pharm.,

QP and QA project manager

Product batch release managements, experience as Responsible pharmacist / Qualified person for product release to EU and Israel Experience in Israel regulatory affairs for pharmaceutical products, registration, re-renewal registration. QA managements for Investigation medicinal products and medical devices production. GMP inspections. IT and Computer-related system validation, GAMP 5 issues, 21 CFR Part 11 and EU Annex 11, QA and Regulatory aspects. Methodology for Engineering and IT complex validation for GxP production computerized equipment and controlling systems. Data integrity-the integrity of the data collected and recorded by pharma manufacturers. Medical devices and combination products related to electronica and computerized programs and /or Bluetooth devices. Well known experience in SAP, MES, BPCS and LIMS systems for quality issues. Alex is Pharmacist, M.Sc. Pharm, graduate with Summa Cum Laude by Tashkent Pharmaceutical University, Uzbekistan. His experience includes the research work in Pharmaceutical, Immunology and Solar energy for chemical synthesis fields. More than 28 years’ experience in Quality assurance of pharmaceutical dry, wet and sterile production in Israel. QA, QP and pharmacists team management on Teva Kfar-Saba and Jerusalem plants.

Product batch release managements, experience as Responsible pharmacist / Qualified person for product release to EU and Israel Experience in Israel regulatory affairs for pharmaceutical products, registration, re-renewal registration.
QA managements for Investigation medicinal products and medical devices production.
GMP inspections.
IT and Computer-related system validation, GAMP 5 issues, 21 CFR Part 11 and EU Annex 11, QA and Regulatory aspects. Methodology for Engineering and IT complex validation for GxP production computerized equipment and controlling systems.
Data integrity-the integrity of the data collected and recorded by pharma manufacturers.
Medical devices and combination products related to electronica and computerized programs and /or Bluetooth devices.
Well known experience in SAP, MES, BPCS and LIMS systems for quality issues.
Alex is Pharmacist, M.Sc. Pharm, graduate with Summa Cum Laude by Tashkent Pharmaceutical University, Uzbekistan. His experience includes the research work in Pharmaceutical, Immunology and Solar energy for chemical synthesis fields.

More than 28 years’ experience in Quality assurance of pharmaceutical dry, wet and sterile production in Israel. QA, QP and pharmacists team management on Teva Kfar-Saba and Jerusalem plants.