Highlights:

Skills:Regulatory, FDA, ISO9001, ISO13485, Pharmacovigilance, GMP

compliance and regulatory manager 9/2011 - 12/2012
Sartorius Stedim, , Tunisia
managing the regulatory files of each medical device and survey the conformity of the manufacturing to the GMP and ISO rules
RESPONSIBILITIES: -Guarantee Compliance With The Regulations and standards for the manufacture of medical devices for European and US market (ISO9001, ISO13485, GMP) - Regulatory insurance - Monitoring and updating of technical files of products - Charge of customer audit and certification audit and internal audit - Place the audit program and monitoring - Interface with other international quality managers of the company--
Pharmacist in chief 12/2009 - 4/2011
SOFAMM, Tunis, Tunisia
Guarantee the commercialisation of the manufactured medical devices on the Tunisian and European market, by getting all the required conformities from the tunisian authorities as the health ministry
RESPONSIBILITIES: - Develop technical records of medical devices products - Deposit and monitoring requests for and commercialization of new medical devices - Approval and submission to the Department of Public Health reports of industrial batch validation process - Approval of reports analyzing sterilization and stability of the products manufactured - Purchase of raw materials and approval of suppliers of raw materials - Final product release by the standards of good manufacturing practices GMP - Preparation of annual research and development company--
Pharmacist in research and development 02/2009 - 12/2009
UPSA SAID, Tunis, Tunisia
Assist the development program of different projects for tablets and ointment and assist the regulatory aspects for releasing new products
RESPONSIBILITIES: - Develop a new formula antifungal tablet - Define raw material supplier - Attending the responsible regulatory affairs (Technical files) - Further stability studies of intermediate materials - Assist in the implementation of a new software ADONIX--
Pharmacist 4/2008 - 01/2009
Boujemaa Pharmacies, Tunis, Tunisia
Insure the legal duties of a pharmacist in his pharmacy such as dispensing medicines, survey the drug prescriptions and insure being a medical advisor for all patients
RESPONSIBILITIES - Dispensing drugs - Monitoring prescriptions for drug interactions - Make all types of injection prescribed for patients--

Faculte de Pharmacie de Monastir Tunisie 09/2001 - 02/2008
Monastir, , Tunisia
Degree: Doctoral Degree
Major:pharmacist
University studies to get a doctor in pharmacy national tunisian degree

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