Mohamed Salah BENZAID

En résumé

Entreprises

• GlaxoSmithKline - Regulatory CMC compliance consultant

  Marly-le-Roi 2016 - maintenant involved in the company’s regulatory activities related to new & existing products, on a domestic or international basis.
  - Writing CMC parts of regulatory life cycle variations/supplement for all destinations
  - Writing Module 2 of regulatory files derived from completed eCTD Modules 3
  - Writing Responses to Questions raised by Regulatory Authorities on CMC matters
  - Support to transversal Regulatory CMC activities

• GlaxoSmithKline - Regulatory Operations Customer Services (ROCS) Agent

  Marly-le-Roi 2016 - 2016 - Responsible of support & consolidate the regulatory project team (RPT) planning & tracking for project/products under responsibility
  - Create & update the company's regulatory information management system (RIMS) with everyday information provided by RPT for all GRA submission activities
  - Responsible for manufacturing change control entries (RPC-request for process change)
  - Responsible for the pre-publishing (creation of the structure within the company's electronic document management system & RIMS)

• GlaxoSmithKline - P&ID’s conformity project

  Marly-le-Roi 2016 - 2016 - Verification of P&IDs conformity with existing situation as Built and identification of each added or removed instrument, type of connection, new groups or systems.
  - Walkdowns through the technical installations over the whole site GSK, Wavre and Rixensart.
  - Up to date existing P&IDs with existing situation.
  - Annotate gaps between drawings and reality
  - Classifying the PIDs according to complexity and conformity
  - Create a timing grid for each types of system based on the actuals

• GlaxoSmithKline - Quality documentation alignment vs QMS

  Marly-le-Roi 2015 - 2015 - Identify the convergence zones and gaps between local documents and corporate documents
  - Gap analysis and discussion with SOP owners to confirm gaps and assess the associated risks
  - Determine mitigation/remediation plan
  - Documentation of related topics

• ALTRAN BeLux - Consultant

  2015 - maintenant

• PHARM'ADIS et ACTIV'ADIS - Missions in Qulity Assurance

  Clermont-Ferrand 2014 - 2014 - Validation of procedures dematerialization
  - Validation protocol & report writing
  - Tests execution
  - Elaborate a good practices guide for production team leaders
  - Batch records Review
  - Atendance during clients audits and inspections

• Nadpharmadic - Production pharmacist

  2010 - 2013 - Write equipment’s standard operation procedures
  - Attendance during SAT
  - Batch record templates creation
  - Process Validation & cleaning Validation
  - Manage and coordinate production activities
  - Validation batches production for products registration
  - Follow-up of deviations, change control, CAPA and failure investigations

• Officine - Pharmacist

  2009 - 2009

• Neomedic - Responsible of production

  2009 - 2010 - Organize and plan production activities according to technical requirements
  - Process validation for 12 products
  - Supervise manufacturing and packaging activities
  - Problem solving & batch records Review
  - Production team management of 20 to 30 persons
  - Production equipment Mastery e.g. Fluid bed dryer, mixer granulator, compression machine, capsule filling machine, blistering machine.

Formations

• Université Clermont 1 Auvergne (Clermont Ferrand)

  Clermont Ferrand 2013 - 2014 Master II Chef de projet en développement de produits pour la pharmacie et la nutrition

Réseau

• Charif Zakaria BERROUANE

• Hamza BECHLEM

• Hamza BOULECHAOUR

• Malik ZEMIRLINE

• Mehdi AMAZOUZ

• Mohamed Lamine KHELIFA

• Takfarinas GHOUT