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Carine BERTOLLA

Levallois-Perret

En résumé

Mes compétences :
LC-MS
Lcms
Methodes
Méthodes analytiques
Spectrométrie
Spectrométrie de masse
Validation
Validation de méthodes
Validation de méthodes analytiques

Entreprises

  • Keyrus Biopharma - Regulatory Affairs trainee

    Levallois-Perret 2015 - 2015 Providing technical, scientific, administrative support to the Regulatory Affairs department.
    > Preparing regulatory documents for initial/ amendment/ notification submissions to the relevant regulatory bodies (Competent Authority, Ethical Committee, others) for the clinical trials authorisations
    > Screening Competent Authorities websites for regulatory surveillance to create the RA newsletter
    > Searching on Data Protection in Europe (Directive 95/46/EC) regarding regulatory, especially for UK (Data Protection Act). Writing working instructions related to the project
    > Exploring EU countries specifications for clinical trial application and non-interventional studies
    > Helping with the preparation of the business proposals: scientific project-related research
  • Lab Support, a division of On Assignment - Associate recruiter

    2012 - 2014 Lab Support, a division of On Assignment, is an international leader in placing scientific and engineering professionals in contract, contrat-to-hire, and direct hire opportunities. Having pioneered a specialized staffing approach, most Lab Support Staffing Consultants possess a degree in science or engineeering and a passion for the industry they represent. With over 25 years of experience, we successfully place professionals in industries such as biotechnology, medical device, pharmaceutical, food and beverage, environmental, chemical, and consumer care as well as government and academia.

    Role :
    Recruiting and placing R&D, QC, QA technicians, and supervisors in pharmaceutical, chemical, food, medical device industries for temporary and permanent positions

    Tasks :
    > Developing a whole candidate database from scratch
    > Building good relationships with candidates and clients
    > Understanding client needs
    > Sourcing candidates, screening CVs, conducting interviews and managing the whole recruitment process
    > Advertising vacancies appropriately by drafting and placing adverts in a wide range of media
    > Using candidates’ database to find the right person for the client’s vacancy
    > Requesting references and checking the suitability of applicants before submitting the CV
    > Writing summaries of interviews in French and English
    > Participating in job fairs
    > Coaching candidates on CV and interviews

    Followed trainings:
    > Time management (2014), STAR method (2014), Develop your creativity (2013), Assertiveness (2013)
  • Département de Pharmacie, FUNDP, Namur - Researcher

    2002 - 2010 Managing research projects linked to analytical and organic chemistry.
    > Using literature to develop and improve original protocols
    > Collecting, reviewing and analyzing experimental data
    > Gathering results, writing reports and articles
    > Following international guidelines (ICH Q2) to validate analytical methods
    > Collaborating with industrials and academics
    > Coaching collaborators and helping in resolving their problems regarding their analytical projects (HPLC, LC-MS)

    Projects
    > Designing and synthesizing original site-specific drug delivery systems based on cyclodextrins followed by evaluating their recognition abilities towards several targets (main project).
    > Developing LC-MS methods to analyse and characterize new products.
    > Designing, developing and validating a LC-MS method to determine drug concentration after Caco-2 cells permeability assays.
    > Designing, developing and validating a LC method to determine glucosamine concentration in plasma. (client : Kitozyme)
    > Analysing drug composition after storage by LC-MS: quantification of drug degradation products. (client : Galephar&SMB)
    > Analysing and comparing HEPES batches by LC-MS. (client : Pfizer)
    > Synthesizing about 30 original compounds as potential inhibitors of serine protease using microwave chemistry.

Formations

  • CEFOCHIM (Seneffe)

    Seneffe 2015 - 2015 CLINET - Expert in Clinical Research

    2-month intensive training
    - provides necessary background to be efficient in functions associated with clinical trials such as CRA, Medical Writer, Data Manager, Clinical Project Manager
    - includes : Regulatory Affairs, Post-Marketing surveillance, Pharmacoviligance, Health economics, Clinical development plan, GCP, GLP/GMP, Publication management, Pharmacokinetic
  • Facultés Universitaires Notre Dame De La Paix (Namur)

    Namur 2002 - 2010 Pharmaceutical sciences
  • Université Montpellier 2 Sciences Et Technique Du Languedoc

    Montpellier 2001 - 2002 Chemistry of Biomolecules
  • Lunds Universitet (Lund)

    Lund 2000 - 2001 Chemistry
  • Université Toulouse 3 Paul Sabatier

    Toulouse 1997 - 2000 Chemistry-Biology

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