Oleksandr Belinskyi Email & Phone Number

My main areas of resposibilties are:- CQV, DI and CSV/CSA projects management and implementation (20+ projects)- business development, searching new format and Customers needs satisfaction (i.e. project support in a time & materials based contracts, data integrity gap analysis and remediation plans development etc.)- operations management (since may 2023)- engineering team creation and development- corporate startups facilitation (i.e. FemTech initiatvie)Key achivements:• Created cross-functional teams, launched a project office. I’ve began to add specialists of different profiles to the project groups for complex problem solving.• I’ve expanded the portfolio of services with services such as validation of sterilizing filtration, support for the development of information systems from the stage of formation of user requirements, support for projects of new productions from the concept stage, and others.• Adapted new methodologies: CSA (computer software assurance), lean software quality assurance, cascading data integrity assessment (business process mapping and data flow diagrams).

Москва, Россия

- organize and perform qualification of utilities, equipment and systems, process validation and computerized systems validation

Минск, Республика Беларусь

My responsibilities are:- organize and perform equipment, utilities and systems qualification, computerized systems validation (50+ projects);- ISO 17025 accreditation

Киев, Украина

I have been consequently engaging in:- equipment, utilities and systems qualification in order to provide a documented evidence of their GMP compliance (from 2005);- computerized system validation for their GAMP compliance such as EDMS, LIMS, ERP (from 2012);- ISMS (ISO 27000), ITSM (ISO 20000) development (from 2014)Key Achievements:• Our company obtained 7 GMP certificates with my participation starting from 2005• I’ve obtained an experience of SAT and FAT activities with EU-located companies• I’ve started a computerized system validation (CSV) activity in accordance with Annex 11 GMP EU requirements• Information security and service management systems providing in cooperation with IT-department (initial skills ISO 27001, COBIT5)

Education record

Training for HVAC and Understanding Pharmaceutical Sterilization, both 3-days long and pefromed by the experts from UK

Diploma Work & Practice, Biotechnology

Activities and Societies: I have been consequently engaging in: - enzyme reaction modelling (2001); - DNA-chip technology development.

Specialist, Industrial Biotechnology