Organization and validation in accordance with the requirements of the GDP and current legislation of Ukraine;

Validation of pharmacy warehouses, refrigerating chambers, freezers, storage area equipment, computerized warehouse temperature monitoring system, transport logistics systems, refrigerator cars, thermal containers, etc. ;

Development of a validation master plan (VMP);

Development and writing of operating procedures (SOP);

Conducting internal audits;

Development and updating of methodological documentation of QMS at the enterprise. Preparation and management of contracts for verification of measuring devices. Interaction with state bodies for metrological verification of measuring equipment.

Maintenance of annual plan schedules of control and measuring devices.

Passing license checks before state bodies.

Passage of external audits by subcontractors.

• Achievements:
• Filling and adding content for the website of a company in the pharmaceutical industry;
• Preparing content, analyzing it, spell checking, creating content for email newsletters;
• Analyzing data by category, changing and editing the site;
• Creation of news, services, etc. on the website;
• Processing and placing text, pictures, links and other related elements;
• Checking and fixing errors.

• Organizational support for expert examinations and inspections of drug manufacturing facilities for compliance with the requirements of good practices (GMP/GDP);Preparation of draft agreements (contracts, contracts, etc.), acts of expert services, inspections and their processing with Customers;
• Processing and sending responses to the Governing Body of the Institute (State Service of Ukraine on Medicines and Drugs Control) on conducting examinations, inspections, etc;
• Control over the execution of concluded contracts (control over the timeliness of payments, terms of service, rights, obligations, etc;)Ensuring the timely submission of documents and obtaining the necessary visas and permits for the Institute's employees sent on business trips;
• Preparation of draft orders of the Institute for business trips with the indication of agreements (contracts, agreements, travel documents to the places of service provision, visas, transfer services, hotel accommodation, etc.), the duration of the business trip, the place of business trip, the name of the enterprise (production sites, laboratories);
• Endorsement of draft orders of the Institute within the competence of the sectorSummarizing the results of expert work (examinations, inspections) conducted by the Institute's employees for compliance with the requirements of European standards, preparing statistical reports, conclusions on these issues for the Director of the InstituteEnsuring the functioning of the ISO 9001 quality system in the Sector.

Maintaining monthly statistical records:

-results of specialized evaluation of technical documentation on quality, manufacturing technology and control in the process of manufacturing medicinal products to determine their compliance with the requirements of good practices (GMP/GDP);

-Generalization of the results of expert work (examinations, inspections) for compliance with the requirements of European standards,inspections of medicinal products manufacturing sites to confirm compliance with the requirements of good manufacturing practice.

Organizing and conducting validation in accordance with the requirements of GDP, GSP, ISPE, WHO and the current legislation of Ukraine;

Validation of the pharmacy warehouse, refrigerators, freezers, warehouse equipment, computerized warehouse temperature monitoring system, transport logistics system, refrigerated vehicles, thermal containers, etc; Development of a validation master plan (VMP);

Organization of validation works at the company's branches. Participation in the acceptance of equipment (refrigerators, refrigerated cabinets, freezers, thermal containers, monitoring system). Coordination of technical specifications - User Requirements Specification (URS),

Development and writing of operating procedures (SOP)

Development and updating of methodological documentation of the QMS at the enterprise.

Preparation and maintenance of contracts for the verification of measuring instruments. Interaction with state authorities for metrological verification of measuring equipment. Maintaining annual schedules of measuring instruments.

• Preparation of annual plans for qualification tests of engineering systems.
• Conducting initial qualification tests and periodic re-qualification tests, processing test results, writing reports;
• Qualification of cleanrooms, temperature monitoring systems, compressed air systems, purified water production, storage and distribution systems, test design and report writing;
• Qualification, test design and report writing of production equipment: Kilian, Fette tablet presses, capsule machine, fluidized bed units, rotary granulators, mixers, tablet coating units, Marchesini, Enflex packaging machines, etc.
• Qualification of laboratory equipment,
• Preparation of Corrective and Preventive Action Reports (CAPA), control over the implementation of these measures.

• Maintenance of pharmaceutical equipment brands: Kilian, Fette, Marchesini, IMA, Zanchetta, etc;
• Commissioning works with setting of parameters;equipment and preparation for launch;
• Repair work, replacement of parts and assemblies, minor repairs;Interaction with related specialties: technologist, instrumentation specialist, air conditioning engineer.