Varvara Ntzoumanika
Regulatory Affairs Officer at Medicair Bioscience Laboratories SA- Claim this Profile
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Bio
Experience
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Medicair Bioscience Laboratories SA
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Greece
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Officer
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May 2023 - Present
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RAFARM S.A.
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Greece
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Pharmaceutical Manufacturing
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200 - 300 Employee
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R&D Analytical Scientist
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Mar 2021 - May 2023
Instrumentation knowledge of: • HPLC (Waters) • Dissolution Apparatus IV • PSD Mastersizer 3000 (hydro analysis) • UV-vis spectrophotometer • Rotational Viscometer • Tensiometer • Osmometer • Rheometer • Zeta Sizer -Stability screening of samples and development samples (pre stability studies), Assay, Preservative and Related Substances determination, Dissolution Profile and Dissolution Studies (Apparatus IV), Forced degradation studies, Particle Size Distribution studies, Dye Ingress for container closure integrity testing, Dynamic light scattering study, viscosity, buffer capacity, osmolality, specific gravity and surface tension measurements in ophthalmic products. Show less
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QualiMetrix S.A.
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Greece
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Pharmaceutical Manufacturing
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1 - 100 Employee
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R&D Officer
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Jun 2018 - Feb 2021
-Instrumentation knowledge of: • HPLC with PDA detector (Shimadzu) • Dissolution Apparatus I and II • UV-vis spectrophotometer • PSD analysis (hydro and aero dispersion) • IR Analysis -Validation and development of analytical methods for pharmaceutical products -Photostability studies, Stability screening of development samples (pre stability studies), Dissolution profile and Dissolution studies (Apparatus I & Apparatus II), Solubility studies, Forced degradation studies, Method transfer -Samples' preparation while following policies, methods and procedures described in relevant SOP's -Product forms: syrups, oral suspensions, injection solutions, drops, creams, tablets and capsules -Compilation of reports (Analytical Method Validation, Photostability studies, Forced Degradation studies, Method transfer & Analysis results) -Responsible for recording raw data promptly and accurately and in compliance with the principles of GLP/GMP -Data processing (e.g. integration of chromatograms) and results' interpretation -Documenting lab operations in appropriate lab notebooks and instrument logbooks Show less
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Pharmathen
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Netherlands
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Pharmaceutical Manufacturing
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700 & Above Employee
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Student Internship
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Jun 2016 - Jun 2016
Participation in the internship program for graduate students in the facilities of the company Pharmathen S.A., which included familiarization with a variety of stages that are needed for the production and quality ensurance of pharmaceutical products until their final release. Emphasis was given on the following departments: R&D, QC, Scientific Affairs, Pharmacovigilance and Production. Participation in the internship program for graduate students in the facilities of the company Pharmathen S.A., which included familiarization with a variety of stages that are needed for the production and quality ensurance of pharmaceutical products until their final release. Emphasis was given on the following departments: R&D, QC, Scientific Affairs, Pharmacovigilance and Production.
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Education
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Ethnikon kai Kapodistriakon Panepistimion Athinon
MSc, Pharmaceutical Analysis-Quality Control -
Ethnikon kai Kapodistriakon Panepistimion Athinon
Bachelor's degree, Chemistry -
2nd General High School of Vrilissia
Graduation Certificate (Apolyterion), 19.6/20 (Greek rating system)-Distinction