Identification and initiation of GMP relevant deviations in Production and QC. Responsible for Root cause analysis, root cause investigation, risk assessment and re-establishment of GMP environment. Fact, background and data assessment with experts on the “shop floor” for QP relevant decisions. Monitoring the events which lead to deviation and their elimination. Deviation classification and making decision upon preliminary use of the product. CAPA plan making and its implementation, complaints… Show more Identification and initiation of GMP relevant deviations in Production and QC. Responsible for Root cause analysis, root cause investigation, risk assessment and re-establishment of GMP environment. Fact, background and data assessment with experts on the “shop floor” for QP relevant decisions. Monitoring the events which lead to deviation and their elimination. Deviation classification and making decision upon preliminary use of the product. CAPA plan making and its implementation, complaints resolving. Preparation for foreign and domestic Audits and support. eQMS management. KPI monitoring and improvement Show less

Process Control and monitoring of Production activities, GMP compliance, transfer of new products, process and equipment validation, employee training

Designing of technological processes in pharmaceutical industry, project management, GMP compliance, technical drawing, validationField of expertise: Chemical and Microbiological laboratories