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Saber Salem | Elance
 
176985602337900
Last Sign-in: Jan 4, 2015

Saber Salem

   Italy
Ferrara

Overview

Regulatory affairs:
•Review, approval & submission of Marketing Authorization dossier (Tunisian Health authorities)
•Ongoing Master's Degree, Regulatory Affairs (Univ. Ferrara): Registration (eCTD, variation, EMA/FDA), preclinical trials (GLP), clinical trials (GCP, CTA, CRA), market access (price & reimbursement), HTA.

Quality operations:
•Qualified Person : batch release
•Quality assurance management system (Euro GMP):procedures, process validation, CSV, audit, training, OOS, change control & continuous improvement
•Project...

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Skills (10)

Tested
Operations Management
Supply Chain
EHS Management Systems
Compliance
Continuous Improvement
Business Continuity
Pharmaceutical Manufacturing
Quality Assurance
Equipment Qualification
Process Qualification

Employment

Pfizer Tunisia
Logistics & Supply Operations Manager
2009 - 2013
-Manage a team of two persons -Ensure distribution and sales of medicinal products & free medical samples. -Ensure compliance of distribution operations with GMP/GDP. -Ensure design and...
Military Service
Hospital pharmacist
2002 - 2003
distribution of drug, blood & blood by-products and medical devices.

Education

University of Ferrara, Italy.
Master's Degree
-
Faculty of Pharmacy of Monastir, Tunisia
Doctor of Medicine (M.D.)
-
Faculty of Medecine of Sfax, Tunisia
Master's Degree
-
Virtual university of tunis
Master's Degree
-
Overview  |  Job History  |  Resume/C.V.

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Identity
Username
salemsaber
Type
Individual
Member Since
November 2014
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Saber Salem | Elance

Saber Salem