Marika Malyszko

Biography

 Quality Assurance Officer at Pharmaceutical Company. Among the main tasks: Complaints management; Drafting and review of the SOPs; Training management; Review of PQR; Deviation and CAPA management; Change Control management. Good knowledge of management system Trackwise. Quality Assurance Officer at Pharmaceutical Company specialized in the production of sterile dosage forms. Among the main tasks: Batch Record Review activities; Batch Release; Drafting and review of the SOPs (Standard Operating Procedures) relating in particular to the areas of Production, Quality Control and Quality Assurance; storage and distribution activities of documents, cancellation and withdrawal of the true copies of the procedures; ; Drafting of the Users (User Requirements Specification) and Validation Protocols; Suppliers Management: selection, qualification, approval and supervision; Training Management; Drafting of specifications for raw materials and finished products.  

Research Interest

 Quality Assurance