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Nicolas FISCHBACH

Lyon

En résumé

Throughout the years, I have worked in Quality Assurance, Engineering, Validation, Production and Process development environments in different companies. Thus, I have developed a multidisciplinary knowledge, allowing me to possess a comprehensive vision of how a pharmaceutical company works on an industrial level.

My good knowledge of quality systems, project management, technical understanding of production equipments and processes, associated to learning ability and solid analytical skills allows me to work effectively while respecting the norms and to rapidly adapt myself to different work environments.

Mes compétences :
Gestion de projet
Vaccins
Qualité
Validation
Anomalies / CAPA / OOS
Qualification
Change control
Formulation
Ingénierie
Amélioration continue

Entreprises

  • Sanofi Pasteur - Qualité Assurance Manager (Aseptic formulation)

    Lyon 2011 - maintenant Management of quality systems for all projects of the department :
    - Building modification and extension, process modification, equipment implementation or modifications (isolators, weighing system, MES, washing machine, air handling units), product transfer, new vaccine development, compliance projects, subcontracting and partnerships projects, single use system implementation, IS project.
    - Change control strategy and coordination, operational and technical documentation review / approval. Project risk management.

    Management of qualité systems for manufacturing operations :
    - Deviations, CAPAs, and OOS/OOT : quality strategy, review and approval.
    - Detecting and evaluating quality and conformity risks
    - Batch record review, environmental monitoring, simulation of aseptic operations.

    Participation in several audits and regulatory inspections (FDA, ANSM, OMS, ANVISA, COFEPRIS)

    Pharmaceutic permanence for formulation/filling/packaging department

    Team management

  • Akka Technologies - Project Engineering Manager

    Paris 2007 - 2011 Project management for different equipments from design to FAT/SAT/IQ/OQ/PQ : formulation and sterile storage system (with SCADA), mobile formulation tanks, packaging line, autoclave, automatic visual inspection line for vial, leak detection machine, cabinet washing system.

    Technical support for validation and production start-up.

    Technical / operationnal documentation redaction and approval, training of production staff.

  • Novartis - Validation Supervisor

    RUEIL MALMAISON 2006 - 2007 Process and cleaning validation for non-sterile liquid products (formulation to filling).

    Laboratory validation of methods of analysis

    Development of granulation and formulation process on pilot equipment.

  • Segula Technologies - Production Manager assistant

    Nanterre 2006 - 2006 Production of media and supply of material (cleaning/preparation/sterilization) for industrialization department

    Production planning, team management, workshop facilitator.

    Implementation of new tools to manage the activity and increase production capacities.

  • Sanofi Pasteur - Bulk Project Manager assistant

    Lyon 2005 - 2005 Study by numeric simulation of a new industrial process for the bioproduction of viral vaccine by cell culture.

    Carrying out small-scale cell culture and purification tests to feed the numerical model of the process.

    Bottleneck studies, production chronogram simulation, feasibility analysis.

Formations

Réseau

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