1. Page 1 of 2
Z S O L T Ő S Z I
2220 Vecsés, Kiss Ernő utca 7/A
mobile: +36 30 26 96 533 email: oszizsolt@hotmail.com
SUMMARY
QC/QA professional with 15+ years of management experience in the pharmaceutical
industry. Contribution in laboratory management, validation of methods and processes,
qualification of instruments and equipment, product development, supplier audits, training,
and continuous development of quality and safety systems. Preparation of GMP relevant
documentation of the above mentioned projects.
AREAS OF EXPERTISE
Knowledge of GMP, ISO9001, ISO14001 QC/QA management
Improvement of quality systems Regulatory compliance
Investigation of deviations CAPA planning
Change control Investigation of complaints
Supplier qualification Co- and lead auditor role
Risk analysis Safety compliance
Staff training and evaluation Communication in English
PROFESSIONAL EXPERIENCE
QUALITY CONTROL MANAGER 2002 to present
Meditop Pharmaceutical Co Ltd Pilisborosjenő, Hungary
Coordination and management of the quality control operations and activities. Organization
and supervision of validations and qualifications. Evaluation of results and trends in tests,
stability studies and deviations (OOS). Preparation and revision of documents (testing
instructions, specifications, SOPs, stability and validation protocols and reports). Writing
modules of registration documentation for generic drug applications and clinical trials.
Participation in the investigation of customer complaints. Training and evaluating of
laboratory staff. Identification of safety risks, improving laboratory environment. Execution
of audits and writing audit reports. Deputy of the QA director.
LABORATORY HEAD 1998-2002
Meditop Pharmaceutical Co Ltd Pilisborosjenő, Hungary
Organization of the quality control laboratory. Preparation of test specifications, revision of
results release/reject decisions. Ensuring regulatory and safety compliance.
RESEARCH CHEMIST 1997-1998
HUMAN Plc. Gödöllő, Hungary
Development and validation of analytical (HPLC) methods for generic drug development.
RESEARCH CHEMIST 1996-1997
SKW Biotech Co Ltd Budapest, Hungary
Purification of antibiotics.
ANALYTICAL CHEMIST 1996
Gedeon Richter Plc Budapest, Hungary
HPLC analysis of pharmaceutical preparations.

2. Page 2 of 2
RESEARCH ASSISTANT 1995-1996
Kossuth University, Department of Applied Chemistry Debrecen, Hungary
Preparation, modification and structure elucidation of artificial proteins.
EDUCATION
UNIVERSITY DIPLOMA IN CHEMISTRY (Chemist, MSc equivalent) from Kossuth Lajos
University (1990-1995), Debrecen, Hungary.