Samy CHEBBAH

En résumé

Entreprises

• Servier - CVO-Europe Consultant

  Suresnes 2015 - maintenant Validation activities support :
  
  Support in all QA-IS activities of systems validation and operational conditions maintenance:
  - Validation projects follow-up and planning management.
  - Risks analysis in coordination with IT, operational and QA team members.
  - Validation testing support to operational team members (organization, planning, training, tests control).
  - Corrective actions follow-up
  - Support in IS periodic reviews management.
  - Operational teams support in the compliance process for existing systems to reach a validated status (planning ; deliverables writing : RA, URS, FS, IQ, OQ, PQ, VR ; training).
  
  Support in project management (french = AMOA) :
  Support to IT project manager in the project planning, acceptance phase testing, anomalies management, deliverables writing.

• Unither Pharmaceuticals - CVO-Europe Consultant

  Paris 2015 - 2015 Computerized System Validation : Production planning software
  
  - participation in the validation strategy definition
  - validation documentation writing : PDV, Acceptance tests, QI/QO/QP protocols, tests and reports
  - anomalies creation and monitoring

• Genopole - CVO-Europe Consultant

  Evry 2015 - 2015 Utility Validation : validation of the animal house expansion - cleanroom environment.
  
  - participation in the writing of IQ and OQ protocoles,
  - IQ and OQ tests realisation and management of subcontractors activities,
  - ability to enter cleanroom environment,
  - IQ and OQ reports writing,
  - anomalies creation and monitoring.

• Laboratoires de la Mer - CVO-EUROPE Consultant

  2015 - 2015 Participation in SAP (ECC6) computerized system validation :
  
  - traceability matrix implementation ;
  - participation in the writing of OQ protocol and tests ;
  - OQ testing supervision ;
  - participation in the writing of PQ protocol and tests ;
  - PQ testing supervision.

• CVO-EUROPE - Computerized Systems Validation Consultant

  LYON 2015 - maintenant

• Stallergenes - QC Commercial Stability Technical Assistant

  ANTONY 2014 - 2015 Management of stability studies (via LIMS software): protocols creation, results control and implementation, decision propositions.
  Redaction of stability reports according the Ph.Eur. and USP.
  Management of Quality Events (OOS).
  Interaction with technical platforms and Quality Assurance.

• Aubay - Consultant Developer

  Boulogne Billancourt 2014 - 2014 Programming for the insurance industry.
  Programming languages : COBOL / CICS / SQL for DB2 database.

• Stallergenes - Commercial stability consultant

  ANTONY 2013 - 2013 Pharmaceutical industry consultant at Assystem on assisgnement as Commercial stability consultant at Stallergenes.

• Delpharm - Laboratory Technician - Analytical Development

  huningue 2012 - 2013 Quality control and stability validation of pharmaceutical products: HPLC/UPLC.

• Merck KGaA - Project Manager Intern

  Darmstadt 2011 - 2011 Main task
  Management of innovative projects (early phases) into the Consumer Healthcare subsidiary:
  - Project feasibility evaluation,
  - Teamwork with experts of main areas (Business Development, Regulatory Affairs, Medical Affairs, Regional Management, Strategic Marketing),
  - Presentation to the Board for evaluation/decisions about innovative projects (several projects accepted),
  - Project team management,
  - Development of new product concepts,
  - Maintenance of existing projects: evaluation of new concepts for products lifecycle management.
  
  
  Secondary task
  Support the Technical Project Manager and the Femibion platform for Women's health:
  - Participation to NPD team meetings,
  - Meeting minutes writing,
  - Participation to the writing of an Investigator's Brochure...

• Biodyss - Co-founder

  2009 - 2012 Creation and management (Director General) of a biotechnology company and an informatics promoting science tool (Project Manager).

• Institut Curie - Research Engineer Assistant intern

  PARIS 5 2008 - 2009 Immunity and Cancer Inserm Unit U932
  Participation to the evaluation of a monoclonal antibody in cancer immunotherapies.
  
  - Tumor cell lines culture,
  - Production and purification of a monoclonal antibody,
  - Checking of the antibody integrity by SDS-PAGE,
  - Detection of an antigen at the plasma membrane of tumor cells by Flow
  Cytometry,
  - Determination of the specificity of the antibody binding on 3 tumor
  cells lines,
  - Checking of the antibody shedding from one tumor cells.

• Only For Children Pharmaceuticals - Regulatory Affairs intern

  2008 - 2008 Writing of an Orphan Designation Dossier for the European Medicines Agency (EMEA).

• VitamFero - Market study intern

  MONTLUEL 2007 - 2008 Study of the market opportunities of a vaccine for human toxoplasmosis.

Formations

• Institut Sup Biotech

  Villejuif 2005 - 2011 Research & Development in Health

Réseau

• Christophe PRZYBYLA

• David LOIRET

• Jessica BOUTELET

• Marion NAVARRO

• Patrick SIMON

• Silvio LUNION

• Sonia GUILLOT

• Timothee KIRKHUS

• William SIBRAN