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Profil CV N°958524

Profil

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Nom : ****
Prénom : ****
Téléphone : +1**********
Email : ******@******
Né(e) le : ********
Nationalité : *********
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Détails du profil

Types de métiers recherchés
» Métiers de la santé et du social
» Production, maintenance, qualité
» R&D, gestion de projets
Expérience professionnelle
Expérience > 10 ans
» Agroalimentaire
» Chimie, pétrochimie, matières premières
» Industrie pharmaceutique
» Industrie, production, fabrication, autres
» Recherche et développement
Expérience professionnelle: 
12.2019 - 06.2020
Quality Analyst Operations
Emergent Bio-solution
●       Performed internal audits. ●       Reviewed batch records. ●       Liaised with suppliers in addressing nonconformities through investigations. Assess and determine appropriateness of corrective/preventive actions to avoid recurrence. ●       Ensured document lifecycle from generation of document to archival.   ●       Maintained Emergent’s Quality Systems including, but not limited to, Deviations, CAPAs, Change Control, and Management Review in support of manufacturing operations. ●       Participated in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product. ●       Reviewed and performed disposition of raw materials, components, bulk drug substance, and final drug substance. ●       Liaise with contract manufacturers responsible for filling, inspection, labeling, and packaging of product by providing Quality oversight for deviations, change controls, and other quality systems that may impact the company products. ●       Supported the reference and retention programs.    
09.2018 - 12.2019
Quality Assurance Engineer/ Medical device
Gbely Guehi
●       Writing, Reviewing and Updating Standard Operating Procedures. ●       Review Device history record. ●       Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) ●       Developing, implementing, optimizing and testing of new method and process in accordance with quality system. ●       Designing and enhancing and developing functional requirements. ●       Monitoring and evaluating effectiveness and overall designs of the sensor, transmitters and system applications. ●       Recording, analyzing, and reporting various results/data in a timely manner to Senior Management. ●       Purity verification using HPLC ●       Investigating root cause failure of in vivo R&D and clinical in accordance with the quality system (CAPA).
Compétences
•               Strong experience in quality assurance and Medical Device Quality System. •               Designing, implementing and testing of new method and process. •               Working closely with various departments R&D, Quality, to meet quality system    requirements. •               Experience with OOS, CAPA. •               Participating in internal FDA auditing.   •               SKILLS           •               Office 365 ( power BI, Sharepoint) •               SAS, MATLAB •               Master Control, Trackwise, Veeva •               LIMS •               Chemstation, Empower •               Chromatography gas and liquid (GC & HPLC) •               pH meter, microscope •               FDA audit •               Method development and Validation •               Strong analysis and problem-solving skills •               Multitasking skills •               Quick learner •               Great communicational and interpersonal skills •               Fluent in French •               GMP, GCP, GDP, GLP, GAMP •               ISO
Formation
Bac+5 et plus
Depuis 12.2020
Quality Review Specialist
United States Army Research institute of infectious diseases
·       Work with Chief, QARCO, Study Directors, principal investigators, and other key staff to perform Quality Reviews of documents and records associated with nonclinical studies, to include those conducted under FDA Good Laboratory Practice (GLP) requirements. ·        Perform quality review of laboratory study files and records to assure that calculations, content, reference, etc. are technically correct and complete for submission for QA audit. ·        Generate, route and file review QR reports for each quality review ·        Perform quality review of GLP study final reports and other high visibility final reports to assure that calculations, content, reference, etc. are technically correct and complete for submission for QA audit. ·        Coordinate and manage corrective action/ preventive action (CAPA) activities related to QARCO supported studies and processes as directed. ·        Represent QARCO in study and project team meetings, coordinating activities with Study Directors, Principal Investigators and study personnel. The candidate shall coordinate with QAU staff on scheduling and quality standards for submissions for QA audit as well as coordinating the scheduling and tracking for all quality review activities.
Langues
anglaiscourant
espagnoldébutant
françaiscourant
Plus d'informations
dans 1 mois
Abengourou - Abidjan - Aboisso - Adzopé - Agboville - Bondoukou - Bongouanou - Bouaflé - Bouaké - Bouna - Boundiali - Dabou - Daloa - Daoukro - Dimbokro - Divo - Duékoué - Ferkessédougou - Gagnoa - Guiglo - Katiola - Korhogo - Man - Mankono - Minignan - Odienné - San-Pédro - Sassandra - Séguéla - Soubré - Touba - Toumodi - Yamoussoukro - International
Lieu de résidence : FREDERICK
CDI - CDD
26.04.2021
127

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