Alexandra Costea-Marcu
Quality Assurance Specialist at Laropharm- Claim this Profile
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Romanian Native or bilingual proficiency
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English Full professional proficiency
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Spanish Limited working proficiency
Topline Score
Bio
Credentials
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Certificate of graduation of the optional course "Evaluation of the documentation for clinical trials",
UMF "Carol Davila" Faculty of PharmacyMar, 2017- Sep, 2024
Experience
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Laropharm
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Quality Assurance Specialist
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Jan 2023 - Present
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Zentiva
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Czechia
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Inspector
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Nov 2017 - Jan 2023
Main activities and responsibilities: • PQR - in charge with Annual Product Quality Review process. Determine the quality and process defects of the products and identify the possible improvements of the method and process; • Capability in using SAP, LIMS and Track Wise softwares; • Third Party Management; -In charge with the Annual Evaluation Plan of the approved raw material and packaging material manufacturers; -Management of raw materials and packaging materials: - QM approval in SAP system; - LMM approval in Track Wise system; - Deviations, CAPA, Change control, investigation of OOSs on raw materials and packaging materials in Track Wise system and quality documentation verification ; - Responsible for revision and implementation of SOPs; • Material Expiration Extension approval, based on a risk analysis for retesting; • Management and approval of transfer of stocks from one SAP code to another SAP code. Show less
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Intern
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May 2017 - Aug 2017
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Tinos
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Belgium
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1 - 100 Employee
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Farmacia Tinos
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Feb 2017 - Apr 2017
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Education
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2017 - 2020
University Emergency Hospital Bucharest
Residency, Pharmaceutical Laboratory -
2012 - 2017
UMF "Carol Davila" Faculty of Pharmacy
Bachelor of Pharmacy - BPharm, Farmacie -
2008 - 2012
Theoretical High School "Emil Botta'', Adjud
Bacalaureat, Mathematics and Computer Science
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