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Industrial Pharmacist-Distribution Operations, Manufacturing & Quality Management Expert

Technical Consultant #2536


Expertise

  • Quality management system: design, Standard Operating Procedures (SOP) training, audit, upgrade quality system.
  • Design of oral dosage manufacturing’s processes.
  • Design of manufacturing process and equipment’s User Requirement Specification (URS).
  • Commissioning and qualification of process equipment, clean rooms, HVAC, purified water system.
  • Market research, business plan, product targeting.
  • Regulatory affairs: Review of parts 1, 2, 3.S Drug Master Files (DMF) and 3.P of marking authorization files.
  • Regulatory affairs: Translation English / French / Arabic of Summary Product Characteristics, product labels, package and patient information leaflets.
  • Management of pharmaceutical production facility.
  • Qualified person: release of raw material & dosage forms batches.
  • Upgrade of quality control procedures, manufacturing procedures and manufacturing batch master.
  • Validation of analytic control contractor and manufacturing contractor.
  • Setting and monitoring of production facility operating and warehouse budgets.
  • Management of warehousing and distribution operations.
  • Upgrade of pharmaceutical distribution and supply operations (operations excellence).
  • Implementation of Environmental Health Management System (EHS). 

Focused Areas

  • Quality tracking system.
  • Balance scored card and decision system.
  • GMP: European, FDA, and WHO.
  • Pharmaceutical and health registration regulation (European , FDA, WHO).
  • Medical device quality management system ISO 9001, and ISO 13485.
  • Quality by design.
  • Equipment qualification and process validation.
  • Management by objective, result driven and problem solving.

Experience

L.D.M.E.D.P, Technical Manager – Pharmacist, 2018 - 2020

  • Running new pharmaceutical facility project:
  • Design of oral dosage manufacturing’s processes and equipment’s URS: powder mixing line, liquid mixing line, powder packing line, liquid packing line, quality control equipment.
  • Commission and supervision of qualification of clean rooms, HVAC system, compressed air system and purified water system.
  • Commission and supervision of qualification of process equipment: powder Blender (Agierre, Italy), liquid mixing and holding tanks (Propack, India), filling powder (MOM packaging, France), bottle and jar filling / capping / sealing / labelling (Afinomaq, Portugal).
  • Setting quality management system, design main procedure and approval of documentation.
  • Site master file and documentation for GMP authorization.
  • Market research, business plan and product targeting.
  • Site master file and health authorization process.
  • Recruiting and training of process and quality teams.
  • Coaching of quality management supervisor. 

Free Lance, Regulatory Affairs Consultant, Qualis, Tunisia. 2017 - 2018

  • Prepared and followed the submission of four Marketing Authorization files of anti-cancer products in Algeria:
    • Review of parts 1, 2, 3.S (DMF) and 3.P of marking authorization files (for each: process validation, quality control validation, stability study).
    • Translation of Summary Product Characteristics, product labels, package and patient information leaflets.
  • Coordination with the local team for follow-up with Algerian Pharmaceutical Agency.

CEVA Animal Health. Tunis, Tunisia, 2015  - 2017

Industrial Production Manager & Qualified Person 

  • Management of production facility: manufacturing, packaging, warehousing and quality operations.
  • Team management (3 supervisors & 25 operators).
  • Qualified person: release of batches (raw material & dosage forms).
  • Upgrade of quality control procedures, regent & reference substance inventory management.
  • Upgrade of quality assurance SOPs and batch master files.
  • Validation of outsourced analytic control and manufacturing.
  • Upgrade of facility to meet GMP requirement.
  • Submission and follow up with health authorities of Marketing Authorization renewal and variation files.
  • APIs: Review of DMF and approval of suppliers.
  • Management of operating budget. 

Medivet. Soleman, Tunisia. Pharmacist technical manager (Qualified), 2013 - 2014 

  • Management of manufacturing and quality operations.
  • Team management (3 supervisors & 25 operators).
  • Qualified person: release of batches (raw material & dosage forms).
  • Commissioning, qualification & submission of regulatory agreement application of new liquid packaging line.
  • Upgrade of quality assurance SOPs and batch master files.
  • Submission and follow up with health authorities of Marketing Authorization renewal & variation files.

Pfizer. Tunis, Tunisia, Logistics & Supply Operations Manager, 2009 - 2013

  • Managing warehousing and distribution operations of finished product (sale and free sample models).
  • Management of support functions (invoicing, maintenance, housekeeping, pest control, security, manpower, purchasing).
  • Management of operating budget management with 10 to 20 % budget saving yearly.
  • Team management (1 supervisors, 3 operators).
  • Upgrade of GMP quality SOPs.
  • Implementing and monitoring of supply chain operations excellence program in the Tunisian, Libyan and Moroccan markets, including gap analysis of supply chain capabilities, coaching for setting plan of actions and monitoring of their achievement.
  • Implemented distribution and supply KPIs.
  • Design and implementation of EHS management system and related SOPs.

Société des Industries Pharmaceutiques de Tunisie (SIPHAT). Tunis, Tunisia, 2006 - 2008

Quality Assurance Supervisor.

  • Validation Master Plan: requalification and revalidation activities (solid and liquid oral dosages, cream and ointment).
  • Upgrade of quality assurance SOPs, batch master files and Site master File.
  • Commissioning, qualification and cleaning validation of new oral dosage facility: granulation (Glatt, Swiss), tableting (Kilian, Germany), coating (Accelacota, UK; Perfima, IT) and blistering (Clockner, Marchezini, IT).
  • Retrospective validation of purified water loop.

SIPHAT. Tunis, Tunisia. Manufacturing Supervisor,     2003 - 2006

  • Monitoring of oral solid dosage manufacturing operations.
  • Supervise manufacturing team (20 operators).
  • Batch file review.
  • Upgrade oral dosage facility SOPs and batch master files.
  • Cleaning validation of process equipment.

Honors & Publications


Credentials

  • Information Technology:  ERP Sage, Quality Tracking, System / Balance Scored Card and Decision System

License

  • Professional Pharmacist (Tunisia).

Languages

  • French - fluent
  • English - fluent
  • Italian - conversation

Publications 

  • Author of Numerous Presentations

Education

  • M.S. Pharmaceutical, Medical Device Regulatory-Affairs, University of Ferrara, Italy
  • M.S. Optimization and Modernization of the Company, Virtual University of Tunis, Tunisia
  • M.S. Occupational Toxicology, Virtual University of Sfax, Tunisia
  • B.S. Pharmacy, University of Monastir, Tunisia
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