Samy Chebbah

Validation activities support : Support in all QA-IS activities of systems validation and operational conditions maintenance

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

Genopôle (client) - 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 (client) - 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.

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.

Programming for the insurance industry. Programming languages : COBOL / CICS / SQL for DB2 database.

Pharmaceutical industry consultant at Assystem on assignement as Commercial stability consultant at Stallergenes.

Quality control and stability validation of pharmaceutical products: HPLC/UPLC, and basic analytical methods (5 months).

Development/Management of innovative projects in the Merck Femibion brand for women health. Project management - Project feasibility evaluation - Teamwork with experts of main areas - Presentation to the Board for evaluation - Project team management - Development of new product concepts - Maintenance of existing projects: evaluation of new concepts for products life-cycle management

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

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

Study of the market opportunities of a vaccine for human toxoplasmosis.

R&D - Health

Biology