Macopharma

Directeur qualité

Medical Devices Industry

PRRC as per requirement of MDR 745
management of quality control lab. 
quality assurance of production, 
quality management system
management of regulatory affairs
upgrade to EU medical device regulation

Quality director & Person Responsible for Regulatory Compliance

Laboratoires des médicaments et premix

Supervised the commissioning & qualification of clean room facility and purified water system: writing and/or review and approval of protocols & reports, 

Ensured the design of URS & choice of process & CQ equipments, FAT, review and approval of DQ/IQ/OQ protocols. 

Supervise the design & implementation of quality management system, 

Ensure the regulatory review and market analysis

qualified pharmacist 

QUALIS SUARL

Registration of generics (oncology) in Algeria: risk assessment, review and approval of CTD file for each product, prepare administrative files for registration, including SmPC, PIL, coordination between customer and Algerian contact

Regulatory affairs freelance consultant

CEVA SANTE ANIMALE

Manufacturing & Control responsibilities: 
-Management of manufacturing, quality control, quality assurance logisitics & maintenance operations
-Qualified Person (raw material & final product batch release) 
-Management outsourcing operations in manufacturing and quality controls
-Management of deviation, CAPA & change control
-Continuous improvement & compliance of quality management system : requalification of equipments; HVAC system’s upgrade; CQ SOPs; AQ SOPs; batch master files

Regulatory affairs responsabilities:
-Chemistry, Manufacturing, and Controls (CMC) review to ensure product’s compliance with the regulations (ICH, EU guideline, local regulation)
-Artwork (labels, packaging and patient information leaflets) approval
-Submissions of pharmaceutical & biological product licenses (new, variation and renewal) in Tunisia & North Africa
-Monitoring and following up with health authorities

industriel site director & head of Regulatory Affairs

EXPERTEAM di De Bortoli Angelo & C

Responsibilities: development of export of in vitro diagnostic kits in the Middle East region.

-Regulatory assessments for the registration of in vitro diagnostic kits in Middle Eastern countries (Oman, United Arab Emirates, Saudi Arabia and Lebanon).
-Due diligence & approval of a new distributor in Lebanon 
-Design & Artwork of product catalog adapted to the needs of the Middle East region.

Business Development

MEDIVET

Manufacturing & Control responsibilities: 
-Ensure manufacturing, quality control, quality assurance & maintenance operations .  
-Qualified Person (raw material & final product batch release) 
-Management outsourcing operations in sterile dosage form manufacturing
-Upgrade of quality management system : SOPs & batch master files
-Commissioning, qualification(IQ/OQ), cleaning validation of new oral liquid packaging line

Regulatory affairs responsibilities:
-Review Martketing Authorization files
-Submissions of pharmaceutical licenses (new and renewal) and following up with health authorities

Technical Pharmacist manager

Pfizer Tunisia

Distribution responsibilities: 
-Warehousing & distribution operations management (sale and free sample models)
-Customer management: order & invoicing
-Management of support functions & contractors: maintenance, housekeeping, pest control, security, safety, manpower.
-Operating budget management 
-EHS Site contact person & Site Security Officer
-Continiuous improvments: upgrade GMP standard operating procedures;  implementation of EHS management system & security procedures
-Desing & implemented distribution & supply KPIs

Operations Excellence Project Coordinator:
-Implementing and monitoring of supply chain operations excellence program in the Tunisian, Libyan & Moroccan markets, including gap analysis of supply chain capabilities, coaching for setting plan of actions and monitoring of their achievement. 
-Main capabilities: Business Continuity Plan, Supply Chain Agreement, Brand Forecast Review, Sales & Operations Planning, warehousing operations, Customs & trade operations

Logistics & Supply Operations Manager

Société des Industries Pharmaceutiques de Tunisie (SIPHAT)

Responsibilities 
-Quality management system: standard operating procedures
-Qualification & validation program of manufacturing equipments
-Audit of production facilities, quality control laboratory and warehouses
-Project coordinator of new oral dosage facility: design of equipment’s User Requirement Specifications and monitoring of commissioning, equipment’s qualification, upgrade of procedures & Site master File.
Main equipment: High shear granulator & fluid bed dryer GLATT, High shear granulator COLETTE, Bin blender GLATT, Tablet press Kilian & IMA-Comprima, Capsule filler IMA ZANASI, Coating pan IMA PERFIMA & MANESTY, blistering & packaging line MARCHESINI & KLOCKNER.
-Retrospective qualification & production validation of purified water station

Quality Assurance Specialist

SIPHAT

Responsibilities: 
-Monitoring of oral solid dosage manufacturing operations: granulation, blending, tableting, coating & packaging
-Batch file & production yields review
-Reconciliation of raw materials and packaging materials
-Deviation & CAPA monitoring
-Monitoring of calibration programs and equipment qualification programs
-Optimizing industrial batch Scale up: granulation & drying 
-Update of master batch files & equipment SOPs : cleaning, maintenance , In Process control
-Collaborated with R&D team for scale up of industrial batch of solid oral dosage form

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