Maria Anna Stamatakou
Chemist
Porto Rafti,I
Summary
Dedicated professional with an over five years of experience, seeking to enhance expertise in analytical chemistry, with a focus on validation of analytical methods. Committed to developing strong decision-making skills and becoming a subject matter expert while ensuring full compliance with regulatory standards (ICH) and industry best practices.
Overview
6
6
years of professional experience
2
2
Certificates
2
2
Languages
Work History
Analytical Reviewer
Adragos Pharma
10.2024 - Current
- Review and analyze stability and validation data to ensure accuracy and compliance with regulatory standards.
- Prepare detailed analytical reports summarizing findings, observations, and recommendations.
- Evaluate chromatographic data and other analytical results to verify method performance and product quality.
- Develop, write, and update analytical methods and validation protocols in compliance with industry standards.
- Monitor and ensure adherence to Good Manufacturing Practices (GMP) throughout testing and documentation processes.
- Investigate and document deviations, preparing comprehensive deviation reports and recommending corrective actions.
- Collaborate with cross-functional teams to support validation activities and stability studies.
RnD Analyst
Adragos-Pharma
03.2020 - 09.2024
- Experienced in preparing quality reports, including analytical results reports and stability reports.
- Assist in the investigation and root cause analysis of analytical quality issues, including OOT/OOS/OOE results, generated during a study and execution of associated CAPA according to internal quality procedures
- Experienced in using chromatography and titration for qualitative and quantitative analysis for stability, transfer and validation study purposes in compliance with regulatory affairs (EMA, ICH).
- Trained to maintain strict compliance with all safety regulations, accepted laboratory practices, standard operating procedures (SOPs), and good manufacturing practices (GMP).
- Trained to troubleshoot analytical issues related to the analysis or the equipment (HPLC)
Chemist (Apprenticeship)
Chion
04.2019 - 05.2019
- Supportive assistance with responsibilities the measurement of iodine in salt.
Education
MSc - Medical Chemistry: Drug discovery and developement
University of Patras
02.2020
Bachelor - Chemistry
University of Patras
06.2017
Skills
HPLC (High-Perfomance Liquid Chomatography) - Experienced
Certification
Troubleshooting seminar, Chimiki techniki June 2024 - June 2024
Interests
Member of Hiking team, Volleyball, Diploma of rock climbing (begginer level)
Timeline
Analytical Reviewer
Adragos Pharma
10.2024 - Current
RnD Analyst
Adragos-Pharma
03.2020 - 09.2024
Chemist (Apprenticeship)
Chion
04.2019 - 05.2019
Bachelor - Chemistry
University of Patras
MSc - Medical Chemistry: Drug discovery and developement
University of Patras
Languages
English (ECPE) - Very Good
Italian - Good
Tour Leader
- Currently training to become a professional tour leader with a focus on hiking, nature, and archaeological tours.
- Enthusiastic about guiding immersive and educational experiences that connect participants with natural and historical sites.
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