Обязанности и достижения:
• Certification (validation, qualification) in full compliance with GMP and the standard (GOST) Р 52249-2009;
• Validation of computerized systems (IQ, OQ/PQ stages);
• Qualification of the equipment assembly and installation location (Installation Qualification – IQ), qualification of key systems operation (Operation Qualification – OQ), qualification of operating performance (Performance Qualification – PQ) of:
• Clean rooms and clean zones
• Boxes of microbiological safety
• Hot-air sterilizers (hot-air cabinets)
• Hot-air and water-jacketed temperature-controlled cabinets
• Incubators
• Refrigerators and deep-freezers
• Laminar flow boxes
• Elaboration of protocols for qualification stages IQ, OQ, PQ;
• Installation and putting into operation commissioning of laminar flow boxes, clean areas, different equipment for clean rooms;
• Replace and installation filters in the local clean areas, decontamination microbiological safety cabinets
• Developing for the the testing laboratory SOPs, instructions and documents the validation of production