Izabela Andruszewska

• Working in accordance with the requirements of FDA, ICH and GMP
• Performing chemical tests (HPLC, GC, TLC, UV, IR) of medicinal products and active substances API in accordance with relevant procedures and specifications
• Developing, evaluating and reviewing procedures, SOPs
• OOT (out of trend) and OOS (out of specification) results investigations
• Transfers and revalidation of HPLC analytical methods
• Stability testing of medicinal products
• Operating analytical devices

• performing chemical analysis of medical products Released Products, In-Process and active substances API with chromatographic methods HPLC, GC, TLC.
• operating an analytical equipment and chromatographic devices,
• developing results of chemical analysis using analytical software,
• Performing analysis in accordance with Eur.Ph. analytical methods,
• In collaboration with a foreign pharmaceutical company I was responsible for an analytical part of the project concerns assay of active substance, purity and stability of the pharmaceutical product
• giving an opinion and evaluating pharmaceutical documentation CTD
• calculating the budget for the analytical projects
• performing the optimization and validation of analytical methods and statistical evaluation of test results as a verification of suitability of the method used,

• working with laboratory equipment used in the manufacture of cosmetics,
• preparing cosmetic products: lotions, shampoos, emulsions, gels,
• optimizing the cosmetic compositions to obtain a product with the correct properties, meeting the requirements of the prospective client