Céline Dugué

Céline Dugué Email and Phone Number

france, aquitaine, france
Céline Dugué's Location
Greater Le Havre Area, France
About Céline Dugué

Céline Dugué is a Inspecteur BPL at ANSM Agence nationale de sécurité du médicament et des produits de santé. They possess expertise in gmp, validation, quality assurance, bonnes pratiques de laboratoire, sop and 2 more skills.

Céline Dugué's Current Company Details
ANSM Agence nationale de sécurité du médicament et des produits de santé

Ansm Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé

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Inspecteur BPL
france, aquitaine, france
Employees:
604
Céline Dugué Work Experience Details
  • Ansm Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé
    Inspecteur Bpl
    Ansm Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé Oct 2013 - Present
  • Lisi Medical Orthopaedics
    Industrialization Project Manager
    Lisi Medical Orthopaedics Oct 2011 - Aug 2013
    Hérouville-Saint-Clair
    - Project Management: Definition of customer requirements (Field: Medical Devices for Orthopaedics), quotation, project industrialisation. Interaction with various departments (Manufacturing, QA).
  • Lisi Medical Orthopaedics
    Aq Packaging Manager
    Lisi Medical Orthopaedics Jan 2011 - Sep 2011
    Hérouville-Saint-Clair
    - Organisation / Management of the Quality Assurance Packaging service.- Qualifications and validations of cleaning lines, packaging (sealing or welding machines) or recording (ovens, cleanrooms) systems. Management of ISO 7 / ISO 8 cleanrooms.- Quality Assurance activities (Treatment of internal and/or external non-conformities. Implementation and follow-up of corrective actions. Procedure creation and revision, training and re-sensitization of people in charge of aseptic activities. Quality Audits ISO9001/GMP/ISO 13485).
  • Genethon
    Quality Control Manager / Manager Of Gmp Quality Control Operations
    Genethon May 2004 - Dec 2010
    Evry
    - Organisation / Management of the QC service (Field: Sterile drugs for Gene Therapy clinical trials).- Cleanroom environmental monitoring (class A to D). Raw material to finished product inspection.- Definition of the inspection plan (analysis, specification and sampling) for biological and sterile drugs according to the EU/US regulations. Definition, monitoring and analysis of stability studies.- Review and approval of equipment qualification (Biological Safety Cabinet, pH meter ...).- Preparation and validation of procedures (SOP), protocols, specifications. Non-conformity and deviations follow-up. Preventive actions / remediation proposals. Quality Audits GMP, GLP.- Constitution, verification and approval of inspection records for clinical trials products.- Quality Control Representative during AFSSAPS inspection.- Knowledge of regulatory requirements as GMP, ICH, European Pharmacopoeia.
  • Sanofi Aventis / Institut Gustave Roussy
    R&D Engineer
    Sanofi Aventis / Institut Gustave Roussy Oct 2001 - Apr 2004
    Vitry-Sur-Seine /Villejuif
    Design and technological development in vectorology: development of new vectors (adenoviral vectors) for gene transfer.Adenoviral Vector production for Sanofi thematic group customers in France, Germany and US.
  • Sanofi Aventis
    R&D Technician
    Sanofi Aventis Feb 2000 - Sep 2001
    Vitry-Sur-Seine
    Development of cellular and biochemical assays for identifying pro-apoptotic or anti-angiogenic molecules by high throughput screening (HTS).

Céline Dugué Skills

Gmp Validation Quality Assurance Bonnes Pratiques De Laboratoire Sop Glp Bpf

Céline Dugué Education Details

Frequently Asked Questions about Céline Dugué

What company does Céline Dugué work for?

Céline Dugué works for Ansm Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé

What is Céline Dugué's role at the current company?

Céline Dugué's current role is Inspecteur BPL.

What schools did Céline Dugué attend?

Céline Dugué attended Université De Technologie De Compiègne, Lycée Marcel Roby.

What skills is Céline Dugué known for?

Céline Dugué has skills like Gmp, Validation, Quality Assurance, Bonnes Pratiques De Laboratoire, Sop, Glp, Bpf.

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