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Faouzi Mistiri, Quality Control and research laboratory/development manager

Faouzi Mistiri

Quality Control and research laboratory/development manager·AFRIMED, KANPHARMA

Tunisia

Master's degree, البحوث في الأدوية

Work experience

Total years of experience: 22 years, 1 months

Quality Control and research laboratory/development manager

June 2004 - Present

AFRIMED, KANPHARMA

Sousse, Tunisia

June 2004 - Present

Control of the raw materials according to the monographs of the European pharmacopoeia, USP...etc.
Control of intermediate finished product and finished product
Elaboration of the scientific data in the file concerning the application for marketing authorisation for a generic medicinal
product (AMM): Formulation, stability studies, interaction between content and container, optimisation and Validation of the
analytical methods...etc.
Analytical Methods Validation (physico-chemical and microbiological method)
Cleaning validation (equipments and production site)
Manufacturing the pilot batches for new generic medicines
Development of new analytic measurement methods and validation
Qualification of water treatment plant (production of purified water)
Qualification of laboratory analytical equipment
Persons Responsible for Supervising/Monitoring the interns
Preparation of the files of A.M.M.
Elaboration of different procedures quality (Control quality, Quality assurance and production)
Installation of the galenic and analytical developement laboratory
Validation of analytical equipment purchase.
Company industry:
Pharmaceutical Manufacturing
Job role:
Research and Development

Education

كلية الصيدلة

June 2011

June 2011

Master's degree, البحوث في الأدوية

Tunisia

Control of the raw materials according to the monographs of the European pharmacopoeia, USP...etc. Control of intermediate finished product and finished product Elaboration of the scientific data in the file concerning the application for marketing authorisation for a generic medicinal product (AMM): Formulation, stability studies, interaction between content and container, optimisation and Validation of the analytical methods...etc. Analytical Methods Validation (physico-chemical and microbiological method) Cleaning validation (equipments and production site) Manufacturing the pilot batches for new generic medicines Development of new analytic measurement methods and validation Qualification of water treatment plant (production of purified water) Qualification of laboratory analytical equipment

المعهد الوطني للعلوم التطبيقية و التكنولوجية

April 2004

April 2004

Higher diploma, مهندس في البيولوجيا الصناعية

Tunisia

- Waste water treatments, - Production and control of purified water, - Management of bio-reactors and fermenters, - Physico-chemical and microbiological analysis, - Mastery of Chromatographic methods of analysis (CLHP, CPG, CPG-MS, LC-MS…etc.), - Mastery of methods of microbiological dosage of antibiotics: titration by distribution or by turbidimétrie, - Mastery of biotechnological methods (PCR, electrophoresis etc.), - Dosage of the enzymatic activities, proteins, - Rheological studies of foodstuffs, - Heat treatments, preservation and packaging, - Validation of the microbiological and physico-chemical methods of analysis, - Quality control and hygiene, system of quality assurance: procedures and HACCP...etc, - Applied statistics, - Qualification of laboratory and production equipments, - Cleaning validation, - Stability studies for active substance and degradation products, - Medications and their formulation, plastics and packaging, interaction between content and container, - Sterility and bacterial endotoxins test,

Skills

Production
Expert
Production
Expert
Enviromental
Expert
Enviromental
Expert
Analytics
Expert
Analytics
Expert
Development
Expert
Development
Expert
Quality Control
Expert
Quality Control
Expert
Sterility and bacterial endotoxins test
Expert
Sterility and bacterial endotoxins test
Expert
Quality control and hygiene, system of quality assurance: procedures and HACCP...etc
Expert
Quality control and hygiene, system of quality assurance: procedures and HACCP...etc
Expert
Validation of the microbiological and physico-chemical methods of analysis
Expert
Validation of the microbiological and physico-chemical methods of analysis
Expert
Waste water treatments
Expert
Waste water treatments
Expert
Heat treatments, preservation and packaging
Expert
Heat treatments, preservation and packaging
Expert
Qualification of laboratory and production equipments
Expert
Qualification of laboratory and production equipments
Expert
Management of bio-reactors and fermenters
Expert
Management of bio-reactors and fermenters
Expert
Medications and their formulation, plastics and packaging, interaction between content and container
Expert
Medications and their formulation, plastics and packaging, interaction between content and container
Expert
Physico-chemical and microbiological analysis
Expert
Physico-chemical and microbiological analysis
Expert
Stability studies for active substance and degradation products
Expert
Stability studies for active substance and degradation products
Expert
Cleaning validation
Expert
Cleaning validation
Expert
Production and control of purified water
Expert
Production and control of purified water
Expert
Mastery of biotechnological methods (PCR, electrophoresis etc.),
Expert
Mastery of biotechnological methods (PCR, electrophoresis etc.),
Expert
Mastery of Chromatographic methods of analysis (CLHP, CPG, CPG-MS, LC-MS…etc.)
Expert
Mastery of Chromatographic methods of analysis (CLHP, CPG, CPG-MS, LC-MS…etc.)
Expert
Mastery of methods of microbiological dosage of antibiotics: titration by distribution or by turbidi
Expert
Mastery of methods of microbiological dosage of antibiotics: titration by distribution or by turbidi
Expert
Dosage of the enzymatic activities, proteins
Expert
Dosage of the enzymatic activities, proteins
Expert
Production
Expert
Production
Expert
Enviromental
Expert
Enviromental
Expert
Analytics
Expert
Analytics
Expert
Development
Expert
Development
Expert
Quality Control
Expert
Quality Control
Expert

Languages

Arabic

Native Speaker

French

Expert

English

Expert

Memberships

عمادة المهندسين

منخرط

May 2004

Training and Certifications

Training
The Studies of Stability and following levels of impurities
centre formation tunis
Sep 2005
spectral analysis
perkinelmer france
Oct 2010
European Pharmacopeia
centre formation tunis
Aug 2008
GLP and Quality assurance in laboratories
centre formation tunis
May 2007
qualification of equipments
centre formation tunis
Mar 2011

Hobbies and interests

رياضة الرقبي

ستة بطولات و خمسة كؤس شهادة حكم في رياضة الرقبي