Experience

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  Labormed

  Sept 2007 - Mar 2022

  Quality assurance specialist

  Managing of the change control process.Managing the process of Product Quality Analyze and issuing of Product Quality Review.Issuing specific SOP's and active participation at training activities.Active participation in checking of the Batch File Records.Active contribution in investigation of deviation, CAPA

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  Europharm holding sa

  Apr 2022 - Dec 2022

  Quality system specialist

  ▪ Recording and monitoring of deviations;▪ Recording and monitoring the complaints sent to the suppliers and product quality complaints received from customers;▪ Recording and monitoring the CAPA’s and the implementation status;▪ Set-up / up date the product properties for the nomenclator of the company

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  Europharm logistica srl

  Apr 2022 - Dec 2022

  Quality assurance responsible

  ▪ Recording and monitoring of deviations;▪ Recording and monitoring the complaints sent to the suppliers and product quality complaints received from customers;▪ Recording and monitoring the CAPA’s and the implementation status;▪ Periodical training of the personnel with specific GxP process (CAPA, SOPs ,deviation, Change Control)▪ Issuing and up-date the Standard Operative Procedure.

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  Sc pi pharma m&d srl

  Jan 2023 - Apr 2023

  Qualified person and head of quality assurance

  Checking the Batch Records for the product packaged/ labelled;Release the products on the market;Recording, investigate and monitoring the deviations;Recording ang monitoring the change controls;Issuing the PQR s for the products manufactured on site;Issuing the Batch Records;Recording and investigate the product quality complaints received from the customer;Recording and monitoring the CAPA’s and the implementation status

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  Swixx biopharma srl

  May 2023 - now

  Quality assurance specialist/ qualified person

  Monitors legislative and GDP/ GMP changes;Ensure that a quality management system is implemented and maintained in line with EU GMP, EU GDP guidelines and local requirement;Ensures that any additional requirements for specific products are implemented;Participates actively in the review of the procedures implemented in order to streamline processes;Ensuring that suppliers and customers are approved in line with local regulation and Swixx SOPs; Ensures the maintenance of quality and traceability of products in the distribution chain;Collaborates with the Responsible Pharmacist and other stakeholders in the management of outsourced activities that may have an impact on GMP/GDP activities Show less