Maayan Ideses

Experience

• 

  BTG A Ferring Company

  Jan 2011 - now

  Validation of equipment, utilities, process and computerized systems.Validation of electronic Batch Records (eBR).Management of changes, CAPA's, deviations and internal audits.Experienced in Root Cause Analysis (RCA).Authoring, review and approval of SOP's, protocols and reports. Trainer of quality assurance personnel.Aseptic processing and Aseptic Process Simulation (APS), eBR, visual inspection and packaging Subject Matter Expert (SME).Experienced in health authorities audits.Strive for continuous improvement of procedures, techniques and production processes using 'lean' tools. Show less Team member of the Quality unit.QA referent of packaging & visual inspection unit, fermentation unit, clean rooms unit and product technology support lab (PTS).Aseptic processing, environmental monitoring and visual inspection Subject Matter Expert (SME).Continuous improvement of procedures, techniques and production processes.Managment of audits, changes, CAPA's and deviations including use of root cause analysis (RCA) tools.Coordinator of internal audits.Initial implementation of electronic batch records (eBR) up to ‘Go live’.Review, validation and approval of electronic batch records (eBR).Authoring, review and approval of SOP's. Training of Quality unit personnel.Internal trainer of new employees regarding cGMP.Batch record review and approval. Show less Team member in the formulation and filling group.Production from bulk to a finished product.As the SME of the filling system and the aseptic process I participated in the initial qualification of the filling line. I am responsible for the filling suite ongoing operations.Author of sop's, operating manuals and the content-related training program.Training of new personnel.Operating of Delta V controlled systems including sterile filtration and ultra filtration.Working closely with QA ,QC and maintenance staff.Handling of Deviations and CAPA's.Continuous improvement of procedures, techniques and production process. Show less

  • QA Product Release Team Leader

    Jun 2023 - now

  • Validation & Change Control Lead QA Specialist

    Mar 2020 - Aug 2023

  • Product Quality Associate (Quality Operations)

    Jan 2017 - Mar 2020

  • Aseptic Filling SME, Formulation & Filling Technician

    Jan 2011 - Dec 2016