Experience

ADRES Int'l Biotech Consultation & Execution

• Israel
• Biotechnology Research
• 1 - 100 Employee

• Chief Executive Officer

  • Sep 2022 - Present

• COO & Director of QA

  • Feb 2022 - Present

• Director Of QA

  • 2018 - Present

  Our team supports early to advanced stage biotech companies in:Medical QA responsibilitiesQuality management systems set-upOngoing QA support remotely and/or at client’s officesQuality oversight and audits at client’s service providers (CMOs, CROs etc)Establishment and review of quality agreements with service providersMock inspections for European and FDA pre-approval Quality improvement plan preparationsQuality oversight of QC activities as well as review of analytical and bioanalytical method development, protocols and reportsMedical QA responsibilitiesCMC QA oversightAudit performance for Sponsors' service providers Show less

• QA Consultant, Pharmaceutical Industry

  • Jun 2012 - Present

  Medical QAQA follow up for clinical trials in all relevant aspects:Supply chainMedical monitorStudy laboratoriesData transferSource data verificationeTMF activitiesClinical sites auditUnblinded person for a phase 3 double blind studyReview of study specific documentation (e.g. study protocol, ICF, studyplans, working instruction)Unblinded review of protocol deviations for phase 3 studyGeneral QA Activities - Writing, Review and Approval of:o Change controlso Validation protocols and reportso Standard operating proceduresGMP audit reportso Stability protocols reportso Master Batch Records and Executed Batch Recordso Deviation reportso Quality agreementso Suppliers evaluation and qualificationo Developing and implementing quality systems.o Preparation for QP and GxP audits (GMP, GDP, GCP, etc).o Performing internal and external GxP audits for Suppliers and Service Providers. Show less



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Generic R&D QA

  • Mar 2008 - Jun 2012

  Roles and Responsibilities:  Accountable for the Deviations in the Generic R&D division. o Performing investigations (Root cause investigation, Failure investigations and Risk Assessments as part of the deviation processes) o Tracking and trending deviations (Reoccurrences, Systemic issues).  Approving Master Batch Records (manufacturing and packaging documentation).  Approving executed batch records for submission to the regulatory authorities (FDA, EMA, TGA, JP, etc.) and for Bio-equivalence studies.  Preparing and reviewing extensive documents for regulatory authorities audits.  Approving conclusive reports of pharmaceutical products prior to their submission to the regulatory authorities.  Participating in answering Review Letters which are received from the regulatory authorities after product submission.  Writing chapters of the submission file for the regulatory authorities.  Working in a GMP environment. Show less