To whom it may concern,
I gained extensive experience in fields of Research, Quality assurance and Regulatory
affairs. I’m well acquaintance to environments of GMP and GLP. I reviewed, revises SOPs
(in compliance to the FDA, EMEA and BRC guidelines), submitted reports. I performed,
adjust and developed lab methods. I use to working in team environment and to
manage large group of peoples. My experience reflected in:
Internal Audits, prevention and correction actions, SOPs management, annual
and daily reports. QA demand a strict compliance to GMP procedures, but you
still need to be very attentive to the production process. Due to my skill of
intermediary I succeed in preventing conflicts that might appear between
different departments of an enterprise. In maintained the good communication
with methods of “storm braining” and extensive training.
At Trima I was involved in upgraded the Q-soft program which was accessible to
use from different places in the facility. The program allowed immediate dealing
with issues, and shortens the time that needed investigate and solve and it
include risk assessments.
Biochemistry & cellular biology microbiology fields demand usage of Bio-statistics
and R&D data sheets, Monitoring and calibrating of laboratory equipment,
reviewing and preparations of lab procedures and reports and Management of
o Chemical analysis with: HPLC and GC, Chemical Organic, TOC and
o PCR, RT-PCR, restriction digest ligation, DNA/RNA gel electrophoresis,
gene manipulation and design of point mutations. Bacterial transformation,
plasmid isolation and purification, transfection and expression in cell lines.
o Protein analysis techniques such as: SDS-PAGE electrophoresis, western
blots analysis, immuno-precipitation technique, immuno-fluorescence
technique and immuno-staining and like ELISA.
I have guaranteed skills in Statistics (includes bio statistics)
I have knowledge of Monitoring & Regulatory, (like IRB and AEs)
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