ronit yafeh
associate director, analytics and quality
About
Over 20 years of experience at TEVA, a leading global pharmaceutical company, of which, over 13 years of experience at an analytical R&D laboratory for generic drugs and over six years of experience in analytical quality assurance. Experience includes: * Project coordinator at an R&D analytical laboratory (development and validation of analytical methods) * Researcher, QA department, in charge of QC laboratories: - Ensure compliance to SOP, GMP and regulatory requirements - Review and approval of Validation & TT of analytical methods - Conduct of periodical internal inspection - Review, approval and closure of OOS Investigations - Support lab in external inspections
israel
israel
pharmaceuticals
chemistry, pharmaceutical industry, gmp, fda, analytical chemistry, hplc, sop, biochemistry, r&d, quality assurance, standard operating procedure, technology transfer, quality control, laboratory, research, chromatography, analytical method validation, microsoft office, organic chemistry, uv/vis, dissolution, trackwise, capa
Experience
associate director, analytics and quality
vidac pharma
quality assurance
teva pharmaceutical industries ltd.
quality assurance section manager
teva pharmaceutical industries ltd.
quality assurance , quality control and r and d laboratories, researcher
teva pharmaceutical industries ltd.
chemist, lead laboratory
massachusetts department of public health
Responsible for chemical analysis of lead levels in human blood using Atomic Absorption Spectrophotometer.
analytical r and d division: project manager, generic controlled drug delivery group
teva pharmaceutical industries ltd.
Responsibilities included conducting analytical development, support formulation development and coordination of all analytical activities related to generic pharmaceutical product development: (i) Implementation/development of analytical methods for generic products (solid dosage forms), especially drug delivery systems (such as controlled release, sustained release, etc.). (ii) Validation of all relevant analytical procedures according to SOP, USP and FDA requirements (including the preparation of validation protocols, validation reports, etc.). (iii) Conducting initial stability tests (including all the relevant specification reports and certification of Analysis). (iv) Conducting developmental and routine tests using analytical methods at the R&D laboratory (e.g. Dissolution tests, Assay and IDD determination, HPLC and UV methods).
Education
bar - ilan university
chemistry
the hebrew university of jerusalem
chemistry
The Casali Institute of Applied Chemistry (1991). Thesis: “A New Approach for the Simple and Economic Preparation of Inorganic Bromide Salts”, Industrial and Engineering Chemistry Research, Vol. 31, 1992 (with O. Arrad and Y. Sasson).
ronit yafeh's Contact Information
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