Karine ALCALA

En résumé

Entreprises

• Asterie - Assistante Affaires Réglementaires - Qualité

  Brignais 2017 - 2018 - Qualité : Mise à jour : des étiquettes, des documents et fiches techniques, des enregistrements de production
  - Gestion de projet international : création des dossiers d’homologations des produits, organisation avec les différents intervenants pour la constitution des dossiers.
  - Veille réglementaire, analyse d’impact de la réglementation européenne DM 745/2017.

• MERIAL SAS - Coordinatrice Affaires Réglementaires

  TOULOUSE 2017 - 2017 - Gestion et administration de la base de données réglementaires : maintien à jour des références (ex : produits, ingrédients, sites de production)
  - Création de processus de tests de la base de données réglementaire
  - Production de rapports sur la base d’extraction d’informations de la base de données (ex : indicateur de performance, suivis de données manquantes)

• - - Expatriation en Californie

  Paris 2014 - 2016 Expatriation de 2 ans au coeur de la Silicon Valley :
  
  - Amélioration de l'anglais avec une immersion totale et des cours à l'université de Stanford.
  
  - Organisation de l'expatriation : obtention des visas, installation sur place, démarches administratives...
  
  - Élargissement de mon champ d'application de travail avec le suivi de la formation "Online basics of European Regulatory affairs" (TOPRA) financée par une bourse obtenue à l'université de Stanford.

• Dietetique - Dietician trainee

  2014 - 2014 Dietitian trainee in 5 institutions:
  
  - Dietetics department, Saint-Etienne Hospital (1 month) and St-Julien-en-Genevois Hospital (1 month), France.
  Personally tailored advice based on patient health history, eating and exercise habits, and preferred foods to manage chronic diseases and improve health. Patient cases in cardiology, nephrology, gestational diabetes, geriatrics, etc.
  
  - Swiss league against cancer (1 month), Lausanne, Switzerland.
  Lead discussion groups on nutrition for cancer patients.
  Documentation writing on vitamins, iron and calcium, and a booklet on Alimentation and Cancer including a scientific literature review
  
  - Institutional catering (2 months), France.
  Cooking, planification of healthy menus following french regulations, food safety prevention (Hazard Analysis Critical Control Point, HACCP)

• Sicpa SA - Regulatory affairs specialist

  2012 - 2014 - Management of a 40,000+ chemical products database (SAP) to summarize chemical and regulatory information.
  - Review chemical, food and pharmaceutical contact laws of 10+ countries/regions (USA, EU, Switzerland, Japan, China, etc) to assess the compliance of our final products.
  - Collaboration with 80+ suppliers to obtain updated regulatory information.
  - Attend 4 conferences around Europe to stay at the cutting-edge of food contact.
  - Participate in the development of a new module in SAP for food contact data management.
  - Participate in the development of a BI solution to summarize relevant information from the entire database.

• Sicpa SA - Regulatory affairs assistant

  2011 - 2012 - Data quality maintenance and data management (SAP, Access) of 40,000+ chemical products database to summarize chemical and regulatory information.
  - Proactive regulatory surveillance (REACH - European Union law-, OCHIM -Switzerland law) to prepare submission documents of 1000+ chemical raw materials.
  - Collaboration with 80+ suppliers to obtain updated regulatory information.

• Policlinique Médicale de Lausanne - Biostatistician

  2010 - 2011 Main studies: Evolution of weight change after smoking cessation, association between obesity and colorectal cancer screening
  
  -Analyze a dataset of 500 participants using advanced statistical methods to study the weight evolution after smoking cessation.
  - Conduct a statistical study on a dataset of 940 participants to evaluate the link between colorectal cancer screening rate and obesity or overweight.
  
  -Collaborate to two scientific publications with a diverse team of physicians.
  

Formations

• CNED

  A Distance 2012 - 2014 Dietetics degree including :
  - Nutrition for person in good health (newborns, children, teenagers, adults, pregnant, elderly person)
  - Nutrition for pathologies : heart health, digestive system, endocrine system, kidney disorders, ...
  

• INSA De Lyon

  Villeurbanne 2008 - 2010 Master
  
  Main subjects: Biology (Pharmacology, Epidemiology, Biochemistry, Immunology, Microbiology,
  Genetics), Computer Sciences (Database management, Programming) , Statistics and experimental
  design, Applied Mathematics , Project management, Communication.
  
  

• Université Lyon 1 Claude Bernard (Villeurbanne)

  Villeurbanne 2005 - 2008

Réseau

• Damien BINOIS

• Elodie PARRINELLO

• Florian CHAPUIS

• Jean-Rémy GOUGAUD

• Jean-Yves KLOS

• Lore MERDRIGNAC

• Martine FLORES

• Maxime PETIT

• Miryana KHOUZAM

• Stéphanie LALLIER BIZETTE