Konstantinos Tzolas

Quality Assurance Officer - GMP at BiosanaPharma
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Contact Information
us****@****om
(386) 825-5501
Location
Greece, GR

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Dara O'Halloran, PhD

I had the pleasure to work closely with Konstantinos in a challenging and fast-paced project. He has an acute ability to understand complex topics and provide insightful input, and also is willing to be flexible without sacrificing quality. This while always bringing a friendly and positive attitude to the workplace. I very much enjoyed working with him and look forward to collaborating again in the future.

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Experience

    • 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

    • 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

    • 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

    • 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)

    • 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

    • 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

Education

  • University of Amsterdam
    M.Sc. of Chemistry, Analytical Sciences
    2017 - 2020
  • Vrije Universiteit Amsterdam (VU Amsterdam)
    M.Sc. of Chemistry, Analytical Sciences
    2017 - 2020
  • University of Patras
    Bachelor's degree, Chemistry
    2009 - 2014
  • 5th High School of Patras
    High School Graduate, 18/20
    2006 - 2009

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