NTO IRE-Polyus LLC (until recently it was part of the international group of companies IPG Photonics, which in its best years controlled 80% of the world's production of fiber lasers). Ved. QC and QA specialist is the “architect” of the QMS, who prepared it for certification according to the requirements of the ISO 9001:2015 standard. Starting in 2017, the company entered its 3rd certification cycle with the international Conformity Assessment Body (CAB) BUREAU VERITAS. Since the production of medical lasers and fiber surgical instruments has been launched on the basis of NTO IRE-Polyus LLC since 2019, the first QMS certification for medical devices according to the international standard ISO 13485:2016 was received in 2020 from the Italian CAB and notified body IMQ S.p.A. After the IMQ S.p.A.withdraw its certificate due to European sanctions the Company received another certification to ISO 13485:2016 in 2023 from the Turkish CAB and the notified body ZHUTEST. The prevailing task in connection with maintaining two parallel QMSs in the large Company has a bad tendency – QC/QA employees spend more and more of their working time on making changes to the documentation of the two supported QMS to please external auditors, but not for real improvements of the QMS processes

Development and approval of company’s Quality policy. Identification of training needs required by International GMP guidelines and applicable to existing production. Implementation of regular training program on related topics for the Site personnel. Checks of the trainings effectiveness and monitoring that GMP requirement are followed by all Site employers. Review and Approval of all Site Quality documentation such as SOP’s, Batch Documentation, specifications, written procedures, sampling instructions etc. Implementation of QMS frameworks directed to meet EFfCI’s GMP Guidelines. Review and Approval of all Deviations, Change Controls, OOS, CAPA’s, Risk Assessments, Customer Complaints. Control, monitoring and trending of annual product quality reports(PQRs), results of ongoing stability program, environmental data, deviations, complaints, CAPAs, OOS results from QC laboratory. Regular(on quarterly basis) management review with the Site Management Team. Regular performance of on-site self-inspections and spot-checks. An outside communication with Third Parties: clients, suppliers, authorities, Certification Body’s inspectors in all issues of Site Quality Management. Review and Approval of Quality Contracts and Agreements. Answers to all requests involving Regulatory requirements and other areas applicable to Site Quality Compliance. An outside communication with Third Parties: clients, suppliers, authorities, Certification Body’s inspectors in all issues of Site Quality Management. Implementation of all relevant new authority and certified body requirements and applicable guidelines Hosting all Quality and Certification Body audits and inspections at the Site. Responsible for the audit/inspection CAPA establishment, follow up, timely closure and communication to authorities/certified bodies.

Performing of GMP compliance audits against IPEC-PQG GMP Guide for pharmaceutical excipients, ICH Q7 for API, WHO GMP and EC GMP Guidance for finished medicinal products, GMP/GDP second- and third party audits for storage and distribution of finished medicinal products. GMP products certification against ISO 15378 Primary packaging materials for medicinal products, ISO 22716 GMP for Cosmetics, EFfCI GMP Guide for cosmetic ingredients, ISO 13485 QMS for Medical Devices, compliance assessments to the essential requirements of MDD 93/42 (regarding CE-marking). Internal SGS final audit packs approver for ISO 15378, ISO 22716 and EFfCI GMP Guide of EEMA regional GMP auditors. Conducting of out-door and in-house trainings dedicated to GMP/GDP regulations, ISO 22716 and MDD requirements.

Pharmaceutical Projects Coordinator Engineering and implementation of turn-key big production projects for the customer’s requests/needs. Technological audits of existing sites/technological processes, feasibility assessments and technical consultancies to improve/opti- mise machinery most suitable to the customer’s request. Operative management of glass-melting furnace constituents, Danner tubing lines, ampoules and vials converting machines deliveries to the Borisov Crystal Plant (Belarus’). Sales promotion of Olivotto glass tubing manufacturing ma-chines, OCMI Group ampoules and vials converting ma-chines/lines, Brevetti Angela BFS-equipment, Bonfiglioli. leak-testing and inspection machines, extrusion and plastic moulding machines for manufacturing tools for medical devices, Fedegari sterilization autoclaves.

Complex delivery of materials for Clean premises in pharmaceutical, cosmetic and electronics industries. Roklin Ltd. became exclusive distributor of 5 Italian manufacturers of essential products explotable in “Clean premises” for food and pharmaceutical enterprises. Realization of suppliers to several big pharmaceutical newly constructed plants.

Strategical planning of business development, analysis of market economic situation, advertising and promotion activity. Organization of RepOffice commercial activity, participation in tenders, direct negotiations with customer decision makers, signing of sales contracts. Deliveries of technological equipment to Russian customers, organization of after sale services and spares supplies. Annual sales exceeded 500.000 Euro.

Preliminary feasibility studies for local toll manufacturing(packaging). Rearrangement and engineering of packaging shop at Moscow Pharmaceutical Factory(MPF) to meet RPR’s standards and current GMP requirements. Ordering, acceptance testing, installation of machinery equipment; setting-up and putting into operation of local manufacturing (packaging) operations. Implementation of GMP required standards at local manufacturing shop: working out internal SOPs for packaging and store operations. Asurance of all compliance and QA issues with local Athourities. Carrying out of professional quality audits with RPR’s QA auditors at MPF. Reveal and identification of counterfeit batches of Aventis products at local retail pharmaceutical market in 2000-2002. Development of prospective action plan against counterfeits in the regions: monitoring and finding fakes and «suspicious distributors»; developing of common database; trainings for finding and identification of fakes in major cities (for experts of certification centers, MVD officers, pharmacists). Implementation of measures to secure imported brand original medicines against local falsification. All-Russian withdrawal of several batches of one ampoule injection medicine, wich didn’t met registration dossier specification.

Organization of biochemical and microbiological laboratories and adjustment of routine laboratory practice, mainly to assure 100% incoming control of barrelled caviare in bulk. Implementation of new technologies and effective measures to decrease spoilage of finished goods - caviare in transparent glass jars - from 10 to 1%.

Toll manufacturing of liquid components for immunochemical kits produced locally under license of Hoffman La Roche Company. Practical experience of production activity in ”clean premises” under the GMP requirements. Successful manufacturing start of 4 new types of immunochemical kits .

Head Office for Medical Device(MD) Certification, SGS MD Auditor Update Training Course / MD Lead Auditor

SSC Department, General and particular requirements of EN 60601-1 to electro-medical devices(MD) / Certified MD Auditor

SSC Department, LA Training Course(ISO 9001:2008) / IRCA registered QMS Lead Auditor

Head Office for Medical Device(MD) Certification, MD certification against MDD 93/42/EEC and ISO13485:2003 / QMS Auditor of MD manufacturers

GOST Certification, Software design management for Medical Devices(MD) / Certified Auditor

SSC Department, ISO 22716 GMP Cosmetics Auditor Conversion Course

On-line Educational & Training Center, GMP Bulk/GMP+ for API & Finished Medicines / Certified GMP Auditor

Educational Training Center, Medical Device Packaging and Labeling / Certified professional

Open GMP training Course, "Clean technologies” and GMP rules / Certified professional

MEDICOMS Scientific training complex, Electrophysiological methods for medical diagnostics / Specialist in auriculodiagnostics

R&D Centre, IVD Medical Devices Design and Construction / Certified Technologist

Medico-Biological Faculty, Master in Biochemistry

Technomic Publishing AG, Basel, Switzerland, Certificate

ASENMCO, Certified professional

Hoffmann La Roche R&D Centre in Basel, Certified Technologist

DIAplus, Soviet- Swiss Joint Venture with Hoffman La Roche , Internal certificate

2nd Moscow Pirogov’s Medical Institute, Assessment of of the model glycoprotein carbohydrates availability by laser nephelometry / Master