Oana Maria Tomulescu

Quality Assurance Manager at Dentotal Protect
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Contact Information
us****@****om
(386) 825-5501
Location
Bucharest, Bucharest, Romania, RO

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Experience

    • Romania
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Manager
      • Feb 2022 - Present

      - led the development of a comprehensive quality management system for the company trough ISO 9001:2015, GDP and GMP- developed and implemented new processes to improve product quality control in order to meet customer expectations and present legislation.- identified opportunities to increase efficiency through process improvement initiatives.- managed the team responsible for ensuring compliance with quality and regulatory standards.- representing the company in relation with Heathcare Authorities Show less

    • Pharmacist Responsible Person
      • Sep 2019 - Present

      - improve and consolidate the activities related to GxP- development of project specific to company`s standard operating procedures and workflows - management of all standard operating procedures and specific documents related to the activity flow of the company (deviations, quality complaints, pharmacovigilance activity, audits)- authorization and reauthorization of the company for the its activities: import and distribution of medical devices and drugs;- teamwork with drug suppliers for regulatory, pharmacovigilance and quality activities;- worked with the sales team to ensure that all products met quality standards- preparation for, participation in, and follow up on audits and inspections from Healthcare Authorities Show less

Education

  • Universitatea de Medicină și Farmacie „Carol Davila” din București
    Studii de licență, Farmacie
    2013 - 2018

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