Daniel Plesa Email & Phone Number

Budapest

Analysis of new product formulations using techniques such as HPLC/UPLC, UV-Vis, Karl-Fischer titration, dissolution testing. Developing analytical, chromatographic and sample preparation methods, such as assay, uniformity of dosage units, impurity and related substances testing, and dissolution testing.Development and validation of swab-sampling methods of pharmaceutical ingredient residues for cleaning validation. Writing Standard Operating Procedures.Routine maintenance and troubleshooting of analytical instrumentation. Maintaining stock levels of laboratory consumables, managing the storage of samples and reagents.Coordination of the daily work of 2-3 laboratory assistants, and ensuring that all analytical areas are in a well organized condition.

Budapest

Coordinating the maintenance, calibration and qualification program of the QC department, creating and following-up the annual plan, keeping in contact with the external service partners.Approving of calibration and qualification documentation, keeping up-to-date the instrument files.Participation in evaluation of price quotations for new instruments, purchasing, installation of the instruments, writing handling instructions.Providing training for colleagues about the handling of the instruments, user administration.Supporting the daily operation of laboratory equipment, troubleshooting.Continuous supervision of environmental monitoring systems.Initiating and conducting change controls, deviations, participation in investigations, and taking part in inspections, audits.

Budapest

Participation in the quality control procedures (in-process and API) of the manufacturing processes of antibiotics in a GMP environment, ensuring the continuous production.Conducting sample preparations according to the standard operating procedures, analyzing and evaluating the samples using HPLC/UPLC instrumentation, and giving the results to the plant.Performing Karl-Fischer water determination titrations.Participation in validations, report writings, development of local documentation system after analytical method transfers, preparing quality documents etc.Maintaining the laboratory equipment, troubleshooting, ensuring the proper operation of the instruments.

Budapest

Sample preparation for GC, HPLC, LC-MS measurements (mainly the extraction of vitamins, mycotoxins, antibiotics from various food and feed matrices), furthermore the isolation of various additives, occasionally TLC identifications, HPLC measurements. Acquisition and maintenance of laboratory consumables, and chemicals. Handling and maintenance of laboratory equipment, devices, and management of instrument data sheets.

Budapest

Sample preparation and analytical determination of drug formulations. Dissolution testing, performing HPLC/UHPLC measurements (for assay, impurity and dissolution profile), UV and KF measurements.Degree thesis: UHPLC method development for impurity analysis using software designing and prediction.

Budapest

Summer internship for university.