Chloé Rivaud

Experience

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  Placoplâtre, Groupe Saint-Gobain

  Jul 2008 - Jul 2008

  Technicienne Laboratoire Qualité

  - Contrôle de conformité de la production du plâtre et des plaques de plâtre : analyse de la densité, du taux d’humidité, résistance des plaques, test de la perte au feu.- Compétence acquises : organisation, analyse de résultats, patience.

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  Placoplâtre, Groupe Saint-Gobain

  Jul 2009 - Jul 2009

  Technicienne laboratoire R et D

  - Étude et analyse de la composition des nouveaux produits-plâtre avant décision de fabrication : granulométrie laser, perte au feu, taux d’humidité, résistance à la flexion et la compression.- Renseignement des bases de données de tests en vue de la réadaptation des formulations.

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  Bristol-Myers Squibb

  Jun 2010 - Jul 2010

  Qualification of pharmaceutical equipment - Internship

  - Treatment of deviations to protocols- Check of the conformity of the documentation: installation plans, certificate of conformity, protocols.- Participation in the qualification (IQ/OQ) of a thermoforming machineCompétences acquises : travail en équipe, rigueur, autonomie, réglementation pharmaceutique

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  University of Southern California

  May 2011 - Aug 2011

  Research in Molecular Biology - Internship

  - Deactivation and reactivation of the DNA Polymerase V involved in the Escherichia coli SOS system. - Compétences acquises : planification, initiative, analyse et synthèse de résultats, résolution de problèmes, anglais courant, SDS-PAGE, gel de polyacrylamide

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  FAMAR L'Aigle

  Feb 2012 - Aug 2012

  Continious Improvement Engineer FAMAR

  - Process mapping of the batch record flow of the lyophilized products.- Optimization and harmonization of the batch record documents for the sterile products, - Training of operators to new operating documents,- Analysis of the feedbacks and following with indicators of the use of the new batch records,- Writing and update of procedures.

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  Baxter BioScience

  Sept 2012 - Oct 2016

  Quality Operations BDS Specialist

  - Operational QA representative of deviations and change controls in USP and DSP manufacturing area. QA expertise on investigations and CAPAs. Realization of impact assessments and recurrence analysis.- Realization of GMP inspections in USP and DSP areas,- Suggestion and realization of process and system improvements.- Quality support for Audits and Inspections.- Definition and following of KPI- Modification, following and approval of quality documents.- Review on the floor of batch records according to procedures and compliance requirements.- Trainer on various department activities Show less

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  Shire

  Oct 2016 - Sept 2017

  Release Specialist

  - Release of manufactured products and raw materials in accordance with licensed geographies, pharmacopeia and quality requirements,- Coordination with the Release teams of other sites and Supply department to ensure the delivery of a portfolio of products on international markets,- Participation in Audits and Inspections,- Quality approver and assessor for OOT/OOS and QC changes- Update and approval of quality documents,- Active participation in continuous improvement,

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  UCB

  Oct 2017 - now

  Vendor Quality Lead, Bio DS

  Key contact person for Quality for specific vendors/CMO involved in the manufacture and testing of Commercial Biologics (monoclonal antibodies). - Owner of Vendor Quality relationship : review/assessment/tracking of change controls, deviations, OOS/OOT, annual stability studies, KPI, annual PQR, RA dossier and on-site presence at vendor- Negotiation and setting of Quality Agreements- QA stakeholder for vendor risk management and performance and follow up of mitigation activities- Resolution of quality issues with Vendor- Ensure system alignment between vendor and UCB and facilitate improvement activities- Assist with regulatory and customer inspection at vendors as well as maintain GMP compliance and audit readiness to support Head of Commercial QA before, during and after inspections.- Project driving and support: provide expert advice on operational and general QA activities for projects of Biologics portfolio (process improvement, technology transfers, quality system improvements, etc.).- Process Owner of Quality Agreement Show less