·        Implemented many projects for clients in the field of Pharmaceutical QMS, preparation for regulatory GMP inspections, preparation of associated CAPAs and their successful implementation. All clients and their sites have successfully passed follow up GMP inspections.

·        Advised and consulted Clients on industry perspectives, GMP compliance issues and associated risks.

·        Data integrity assessment, Gap analysis, site remediation planning.

·        Review and guidance related for deviations, investigations, customer complaints and CAPAs:

·        water systems and pharmaceutical gas systems

·        Preparation action plan, and monitoring action plan for site remediation.

·        Ongoing review of OOS and OOT investigations.

·        Perform ongoing review of OOS and OOT investigations.

·        Laboratory equipment qualification.

·        Review the status of the laboratory equipment qualification, prepare action plan, and ongoing monitoring of the action plan.

·        Analytical method validation review.

·        Review status of analytical method validations. Preparation action plan, and ongoing monitoring of action plan.

·        Assessment of computerized systems

·        Ensured that the activities carried out by the businesses in the region are compliant to all relevant legislation and all products are compliant with regulatory requirements.

·        Effectively and proactively supported the Quality Manager to provide leadership for excellence in Quality and Compliance of all Health products and processes within the supply/distribution chain, including embellishment.

·        Led and facilitated quality continuous improvement activities and initiatives in Organization.

·        Implemented processes and procedures related to Quality and Compliance.

·        Served as a resource for information relative to all aspects of products and process quality.

·        Facilitated the ?right first time? approach for implementation of new products and processes.

·        Successfully supported and integrated continuous improvement principles within the region through proactive communication, partnering, training and education.

·        Completed successful implementation of QMS in country organization branch.

·        Communicated with State Administration of Ukraine on Medicinal Products (SAUMP) ?concerning issues appears during quality control of OTC products.

·        Successfully completed the GMP certificates verification procedure which allowed us to bring new products to the market in a short time.

·        Organized an effective process for the translation and verification of CoAs for the rapid release of the produced batches to the local market.

·        Regularly and continuously certified and registered of Cosmetic&Commodity business brands in Ukraine.

·        Carried out Artworks creating and approval flows according to the local legislation requirements.

·        Established a fast and efficient customer feedback and support system (providing with relevant documentation, communication regarding quality issues and docs etc.).

·        Supervised and organized effective work and continuous professional trainings and improvement roadmap of a Group of 8 GMP Inspectors.

QMS:

·        Pharmaceutical Inspectorate QMS management. Risk Management.

·        GMP Inspections:

·        Planning, organizing and leading GMP audits of manufacturing facilities (almost 100 sites throughout the world (India, China, Bangladesh, Pakistan, South Korea, Russia, Belorussia, Turkey, Bulgaria, Iran, Serbia) in last 7 years). Sites types: non-sterile (OSD, liquids, semisolids); sterile (lyo, liquids, powders) biological and non-biological.

·        Preparation audit reports, CAPA assessment, negotiations with site leaders.

·        Training courses:

·        Development of auditor?s skills for national inspection team members (initial and routine training);

·        Planning, organizing and leading training courses for pharmaceutical industry members (http://gmpcenter.org.ua/en/services/navchannja).

·        Cooperation with PIC/S members:

·        Annual meetings participation.

·        Continuously assured that all aspects of the handling and distribution of pharmaceutical products at the site / in the country comply with the requirements of the Novartis Pharma Corporate Quality Manual and Policies.

·        Established effective and robust system of developing, approval, training and implementation of SOPs for all GxP related activities in UA and other 11 region markets including warehousing, deliveries, and recall of goods.

·        Established effective system of monitoring and control for all GxP related activities including warehousing, repackaging, deliveries, and recall operations in UA and other 11 region markets in terms of their compliance with current SOPs.

·        Performed audits, supervising and co-ordination of third party activities and ensure that third party manufacture (re-) packaging, storage and/or distribution of Novartis products is in compliance with Novartis Standards.

·        Continuously and successfully managed external inspections, validation/qualification activities, complaints, recalls according to the Novartis Corporate Quality Manual and local written procedures.

·        Development validation documentation (VMP, DQ, FAT, SAT, IQ, OQ, PQ, PV steps).

·        Validation and Qualification activities managing for utilities (Pure Water, Water for Injections, Pure steam, Compressed air, Compressed nitrogen, HVAC, Cleanroom systems, Sterile filtration systems).

·        Aseptic PV preparation and supervision (Media Fill Tests).

·        Qualification activities managing for pharmaceutical equipment of non-sterile, sterile production: tablets formulation, aseptic powder formulation, sterile liquid formulation, lyophilization formulation, herbal extracts and syrups.