Lead of qualification group

Qualification of clean rooms, production equipment

Qualification of production equipment Take part in SAT

Cleaning validation, equipment validation.

Qualification of: equipment (sterilizing equipment, freezers, refrigirators, reactors, etc.); clean rooms; warehouse mapping. Validation of: transportation process; sterilization process. Documentation development: VMP (GVP); Risk analysis; Qualification protocols (DQ, IQ, OQ, PQ); SOP. Participation in SAT. Work with equipment: Testo 174Н/Т temperature equipment (temperature sensors); Madgetech (temperature sensors); Solair 3100+ (particles counter); Testo 435 (measuring temperature, humidity, air flow rate, pressure). Calculate F0. Programs: Soft for temperature sensors (testo, madgetech) MS Office.

Qualification of: equipment (sterilizing equipment, freezers, refrigirators, reactors, etc.); clean rooms; warehouse mapping. Validation of: transportation process; sterilization process. Documentation development: VMP (GVP); qualification protocols (IQ, OQ, PQ); SOP. Participation in FAT, SAT. Validation and starting of the new ampoules site. Participation in audits: Ministry of Industry and Trade; Global audit from Abbott (AQR); ISO. Work with equipment: Ellab temperature equipment (temperature sensors); LightHouse Solair 3100, 5100; Testo 435 (measuring temperature, humidity, air flow rate, pressure); iBDL temperature loggers. Calculate F0. Programs: iBDL_R; iBDL_MG; MS Office.

Leading the validation team, planning the work process.

Development, maintenance and delivery of projects to improve production processes. Increasing line performance. Preparation of technical descriptions and assignments for suppliers. Development of operational plans.

Organization of production structure in accordance with the philosophy of Lean Manufacturing. Mapping the value stream, determining tact time, production bottlenecks, finding solutions to problems. Implementation and use of tools: 5S System (Sorting, systematization, keeping clean, standardization, self-improvement) - office and production, TPM (Total Productive Maintenance - autonomous maintenance of equipment), elimination of production losses. Conducting trainings in the Beko Academy program.

Tracking defects, reducing defects quantity, improving the process, upgrading the means of production, quality control of manufactured products (molded extrusion sheet, sealing rubber for doors, foam plastic for packaging of finished products, a condenser grille, ready-made freezer and doors. Reporting (TPS), calculation the cycles time, drawing up operational plans, ordering components and additional materials using the SAP NetWeaver Portal, production control through programs: Avigilion, ProView. I have the title of the best teacher at the Beco Academy in 2014.

The chemical analysis of the finished product (shingles), bitumen mixtures supplied to the production of raw materials.

Working with documents of foreign economic activity, tracking deliveries of finished products, working with declarants of the Novorossiysk customs preparation of TD (transfer and verification of invoices, packing, transport invoices, bills of lading, etc.) tracking deliveries from port to regions. Execution of orders of the head.

Worked as a trainee. Analysis of the production line, keeping a log of product quality, work with e-mails, scheduling work.