Martin Bursík

Biography

Experienced (18+ years) quality professional in the field of pharmaceutical industry - knowledge of production portfolio covering sterile (including aseptically prepared) and non-sterile dosage forms, APIs and investigational medicinal products Work in several international teams, cross-functional projects, efficiency and costs management Practical experience with Lean-oriented projects

Research Interest

Key soft skills: - communication and organisational skills, team management (responsible for managing the team of up to 120 people) - analytical thinking - presentation skills - fair, responsible and well organised person, keen on learning new things Key hard skills: - quality systems management - management of quality related issues (deviations, complaints, recalls, CAPA, change control procedures) - internal and external inspection activities (EU authorities, FDA, ANVISA, SFDA and others), certified GMP-auditor - qualification as a Qualified Person according to EU legislation - GMP legislation, QC/QA/RA procedures - pharmaceutical microbiology - good command of MS Office tools and GMP-relevant supporting IT-systems (LabWare LIMS, eDMS, TrackWise, SAP)