Experience

BiosanaPharma

• Netherlands
• Biotechnology Research
• 1 - 100 Employee

• Quality Assurance Officer - GMP

  • May 2022 - Present

  - Maintenance of the Quality Management System in compliance with GMP - Maintenance of Approved Supplier List and participation in Supplier Management activities, external/internal audits and follow-up activities - Maintenance of the Quality Documentation System, including the repository and archive, to remain up-to-date. - Establishment of the training program and the related documentation - Participation in quality communication and setting contracts (e.g. Quality Agreements or equivalent) with assigned contractors. - Daily quality-related communication with CMOs with regards to DS and DP manufacturing - Authorization and approval of deviations, change controls and CAPAs - Review of Batch Records, Component Records and IQ/OQ/PQ protocols Show less



Pharmathen

• Netherlands
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Officer - GDP

  • Jul 2021 - Apr 2022

  - Carried out Commercial Releases of customer's orders in compliance with GDP - Establishment and maintenance of the QMS - Performed customer and supplier license verification activities - Review documents related to product manufacturing and shipment to the 3-PL Warehouse - Authorization of Deviations, CCRs, CAPAs - SAP - Carried out Commercial Releases of customer's orders in compliance with GDP - Establishment and maintenance of the QMS - Performed customer and supplier license verification activities - Review documents related to product manufacturing and shipment to the 3-PL Warehouse - Authorization of Deviations, CCRs, CAPAs - SAP



SUN PHARMA

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Officer - GMP

  • Jan 2020 - Jun 2021

  - Review of batch records and preparation of Batch Release Certificates for QP release in compliance with GMP - Cross-functional communication with warehouse, supply chain, analytical labs, QMS, MAHs, plants and CMOs - Authorization of Deviations, change control, CAPAs - Experience with SharePoint, EDMS, Speura, Trackwise - Assessment of primary and secondary packaging and leaflet of the final product - Trained new personnel - Review of batch records and preparation of Batch Release Certificates for QP release in compliance with GMP - Cross-functional communication with warehouse, supply chain, analytical labs, QMS, MAHs, plants and CMOs - Authorization of Deviations, change control, CAPAs - Experience with SharePoint, EDMS, Speura, Trackwise - Assessment of primary and secondary packaging and leaflet of the final product - Trained new personnel



LIGHTHOUSE Instruments

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Assistant Project Manager

  • Sep 2018 - Dec 2019

  Title of project: “Frequency Modulation Spectroscopy as a tool for Container closure integrity testing” - Preparation and implementation of study plan - Qualification of gas installation system - Sample preparation/measurements with FMS and report writing for customer’s projects - Writing of technical instructions for internal purposes - Analytical instrument qualification (IQ/OQ) Title of project: “Frequency Modulation Spectroscopy as a tool for Container closure integrity testing” - Preparation and implementation of study plan - Qualification of gas installation system - Sample preparation/measurements with FMS and report writing for customer’s projects - Writing of technical instructions for internal purposes - Analytical instrument qualification (IQ/OQ)



CBL Patras

• Greece
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Control Analyst - GMP

  • Sep 2015 - Aug 2017

  • Performed classical and instrumental analysis – HPLC, GC, IEC – of raw materials and final products according to cGMP and EHSS standards • Performed method development for HPLC and IEC techniques • Executed stability studies, instrument calibrations, and performance verifications • Synthesized oligopeptides in the R&D department for internal projects • Performed classical and instrumental analysis – HPLC, GC, IEC – of raw materials and final products according to cGMP and EHSS standards • Performed method development for HPLC and IEC techniques • Executed stability studies, instrument calibrations, and performance verifications • Synthesized oligopeptides in the R&D department for internal projects



Hellenic Air Force

• Armed Forces
• 400 - 500 Employee

• Military service - Chemist

  • Sep 2014 - Jun 2015

  Performed qualitative and quantitative determination of wear materials in oil-lubricating engines and fuels in combustion engines Performed qualitative and quantitative determination of wear materials in oil-lubricating engines and fuels in combustion engines