About
Summary
Dr. Imeda Rubashvili is a highly experienced professional with extensive expertise in pharmaceutical quality management systems, quality assurance/quality control processes, and validation activities in the manufacturing of non-sterile, sterile liquid, and solid dosage form drug products. He also possesses substantial hands-on experience and practical knowledge in pharmaceutical research and development, as well as in technology transfer.
Dr. Rubashvili has accumulated 15 years of leadership experience in the pharmaceutical industry, during which he has held various managerial positions. In addition, he has 10 years of intensive and successful audit experience, serving as a lead internal quality auditor.
Dr. Rubashvili is a scientific researcher in the fields of analytical chemistry, bioorganic chemistry, and pharmaceutical analysis, and he has managed scientific projects for up to 16 years. He is a full professor and also serves as a visiting professor at several local universities.
Alongside his academic and industrial activities, he is engaged in training and consulting, supporting the implementation of GMP and GDP standards in local pharmaceutical companies. His training and consulting portfolio also includes instruction on ISO 17025 and ISO 15189 standards, as well as various analytical techniques, methodologies, and laboratory practices for testing and medical laboratories.
He actively collaborates as an expert with state organizations on topics related to natural and pharmaceutical sciences, laboratory standards, and quality management systems.
Dr. Rubashvili is open to new challenges and opportunities for collaboration within the pharmaceutical industry—particularly in quality management and research and development—as well as within the academic sector in the areas of analytical chemistry, drug discovery, and pharmaceutical and bioanalytical research studies.
Positions
Validation Manager/Head of Validation Department Oct 2022 - Apr 2023
Pharmaceutical Company “GM Pharmaceuticals” Ltd.
Manage all validation/qualification activities (premises/systems/equipment qualification/periodic review; laboratory equipment and instruments qualification/calibration; cleaning validation/verification; disinfection and cleanroom garment washing process validation; verification of transportation; manufacturing and packaging process validation/verification; IT infrastructure qualification and computerized systems validation/periodic review; analytical and microbiological method validation/verification; analytical method transfer) in pharmaceutical production of solid, semi-solid and liquid dosage formulations.
Develop and update validation master plans (VMP); review/approve SOPs, URS, RA, IA, SAT/FAT, qualification (DQ/IQ/OQ/PQ) protocols/reports, TM, VP, validation protocols/repots; maintain up-to-date knowledge of GMP regulatory issues; ensure the company validation policies and procedures; evaluate the performance of validation/qualification activities through KPIs to ensure compliance and maintain equipment/systems/premises in a validated/qualified state.
Participate in pharmaceutical development, technology transfer and quality assurance processes (change control, review of quality management system, product quality review, deviations and CAPAs, supplier and vendor qualification, complaints, records and data integrity and quality control management); perform/review risk and impact assessments and risk mitigation actions; review product development and technology transfer documents.
Metrological supervision; manage internal and external calibration processes in the company; ensure compliance and maintain measuring equipment and instruments; evaluation of measurement uncertainty.
Conduct internal and external quality audits (as a quality auditor of the company).
Visiting Professor Mar 2020 -
Department of Pharmaceutical Technologies and Pharmaceutical Analysis, Tbilisi Medical State University
· Give lectures on the master’s programs “Pharmaceutical and Cosmetic Technologies” and “Pharmaceutical Analysis”; teaching courses – “Good Manufacturing Practice”; “Organization of Pharmaceutical Quality Control”
· Develop syllabuses; prepare teaching materials
Senior Research Scientist Jan 2017 -
Petre Melikishvili Institute of Physical and Organic Chemistry, Ivane Javakhishvili Tbilisi State University
· Carry out extraction, purification and chemical modification/derivatization of natural bioactive compounds from plant materials; stability and forced degradation studies of bioactive compounds, their derivatives and stabilized forms; development of laboratory technologies of agro-industrial wastes for obtaining valuable bioactive compounds
· Carry out analytical research studies by HPLC, GC, GC-MS, LC-MS, FT-IR, UV-Vis, TLC, IC, CE, XRD, porometer
· Investigate fixed bed adsorption and chromatographic separation processes of organic and bioactive compounds; chiral chromatographic analysis
· Manage scientific research grants; write the scientific work reports