Quality assurance

Luc*** ***** (XX Anni)
Quality project manager a Sanofi Belgium
Università Cattolica del Sacro Cuore di Roma
Roma,
Lazio
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Esperienza
Quality project manager
Sanofi Belgium
feb 2020 - Attualmente
- Supporting the yearly Customers check by checking the
validity of license of customer.
- Develop specific Quality documentation community of
practice as to enhance knowledge management and
good practices sharing within the cluster
- Partnering with other (GxP) teams, being responsible for
specific project deliverables and contributing towards the planning and management over project activities to ensure success
- Supporting various Quality projects to improve productivity and customer experience (e.g. support of the Global Quality Documentation Management system (GEODE) for all GxP areas)
- Establishments of elaborate communication material to support the use and understanding of the various projects (e.g. for GEODE, training project, ...)
- Facilitating a timely commercialization process for vaccines (e.g. ‘MIF process) that are delivered to the Benelux warehouses for distribution in the Benelux. Preparing the documentation regarding the release (e.g. release protocol, release bon, EBR, CoA) and providing this information to the CQH for completion and sign-off.
Product assurance bacterial intern
GSK Vaccines
gen 2019 - gen 2020
- Minute writing and corporate meeting reports
- Collaboration in the implementation process of the GSK
Production system in the OMV department
- Collaboration in document simplification projects of
production BPR /MBR
- Support of the team in drafting the DR and CR APR
- Processing data and performance related to weekly and
monthly analysis using presentations (survey tools, CAPAs and
DR).
- Translation from Italian to technical-scientific English of GMP
documents in the areas of Primary Production for FDA
inspection
- Collaboration in the LESS project for the migration of
environmental monitoring data from GLIMS to SAP.
Tirocinante
FARMACIA ALFREDO BERNA & Co Snc, ROMA
nov 2015 - mar 2017
Main responsibilities:
- Warehouse management
- Pharmacy dispenser
- Galenical preparation
Formazione
PRE-CLINICAL AND CLINICAL DRUG DEVELOPMENT: TECHNICAL-SCIENTIFIC, REGULATORY AND ETHICAL ASPECTS”
Università Cattolica del Sacro Cuore di Roma
gen 2019 - nov 2019
Master di II livello
Laurea magistrale in Farmacia
Università degli studi di Roma La Sapienza
ott 2011 - mar 2018

          
        
Lingue
Inglese - C1
Italiano - Madrelingua
Spagnolo - B1
Francese - A2