Oana Maria Tomulescu
Quality Assurance Manager at Dentotal Protect- Claim this Profile
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Bio
Experience
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Dentotal Protect
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Romania
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Assurance Manager
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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
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Pharmacist Responsible Person
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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
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Education
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Universitatea de Medicină și Farmacie „Carol Davila” din București
Studii de licență, Farmacie