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Summary

i am a well-organized person and have good Communication and Analytical Skills. i am result-oriented and eager acquire new skills. i have a valuable experience in modern Biomedical techniques and processes used in fundamental Research and the development of pharmaceutical products. since 2014, i have progressively developed a deep knowledge in Quality Assurance Operations and Regulatory Affairs processes and requirements. i work as scnm (site Compliance network Member) and support cmc (Chemistry Manufacturing and control) changes and quality Operations for drug , biotech and Health consumer products and api. i am familiar with regulatory requirement for the Pharmaceutical Industry and have a quality mind set.

i am looking forward to growing my work experience and enjoying challenges for new responsibilities within qa or Regulatory Affairs departments.

Experiences

Current Experience

  • SCNM (Site Compliance Network Member) in QA and RA


    Since August 2014
    Quality System and Operations support • cmc Change Management to support the life cycle of different products on the market, • product complaints and ancillary requests management • administration support for annual product review and tender requests • quality and regulatory gaps identification and closure plan • deviations and capa management • Compliance assessment for new pharmacopeia • address different requests from regulatory authorities • risk and impact assessment • Quality system and operations support • CMC Change management to support the life cycle of different products on the market, • Product Complaints and Ancillary Requests management • Administration support for Annual product Review and Tender Requests • Quality and Regulatory Gaps identification and closure plan • Deviations and CAPA management • Compliance assessment for new pharmacopeia • Address different requests from regulatory authorities • Risk and Impact Assessment

Past Experience

  • Scientist Trainee

    January 2014 --- August 2014

    r&d in the vaccin generation group:

    design and perform Laboratory experiments, optimize Assays, update sops , Compliance to good Laboratory practices (glp), Research practices (grp) and Manufacturing practices (GMP). invitro and In Vivo cloning, Cell lines (percy6) cultures, HPLC, adenoviruses

     

     

    qc:

    quality trough put process Documentation, GMP environment and Compliance, data generation, management and trending, quality Compliance Testing and inspection as required

  • Assistant Scientist

    February 2013 --- September 2013
    collect and analyze data in order to assess the impact of antiretroviral therapy (art) on the prevalence of helminthic infections and worm load in hiv+ patients. assess the adherence of hiv patients to art regimens/ qualitative study. logistic support: to make sure that the transportation, storage and processing of Clinical study material and participants’ samples comply with the study science)" rel="nofollow">Protocol. administration support: to receive, update, send, submitting and filing of required documents to the src, ec or pi as applicable. to make sure that the information on crfs is generated and documented according to the Research science)" rel="nofollow">Protocol, gcp and ICH guidelines. monitoring of the study progress and management of data, reporting to the principal Investigator, discuss and document Adverse Events.

  • Microbiology laboratory attendant

    October 2011 --- January 2013
    supervise Microscopy practice sessions for bachelors and masters students. teach modern techniques and principles of Microbiology (culture, Microscopy) monitor students for final projects and different assignments.

  • Freelance translator/ interpreter

    September 2007 --- September 2012
    experienced and talented translator and interpreter with ngo's background in drc (congo) and the netherlands. at ease working in English, French, dutch, kiswahili and lingala.

  • Receptionist

    July 2011 --- September 2011
    answer telephone, screen and direct calls ,take and relay messages, provide information to callers, direct persons to correct destination, deal with queries from the public and customers, general administrative and clerical support, prepare letters and documents,organize meetings

  • researcher

    October 2010 --- April 2011
    generate new knowledge about multiple sclerosis: evaluate the effectiveness of small Molecule (valproic acid, ms275) inhibitors of epigenetic processes as novel treatement modality of multiple sclerosis (ms).

Personality

Self Assessment :
Analytical thinkingAdaptabilityAuthenticityFlexibilityInterest in knowledge

Knowledge

LinkedIn Assessment :
EnglishFrenchQualitative ResearchLife SciencesInfectious diseasesScientific WritingscienceBiomedical SciencesdutchIntercultural CommunicationInternational RelationsEpidemiologyResearchSubtitlingImmunologyWestern BlottingLiterature ReviewsZebrafishLifesciencesLinguisticsQuantitative ResearchRegulatory affairsQuality AssuranceClinical research

Skills and Expertise

Self Assessment :
Analytical skillsAssemble regulatory applicationsBiomarker ResearchCell cultureChemistry Manufacturing and Controls (CMC) activitiesCollaborate with principal investigatorCollect data

Education

  • Bsc in FALW/ Biomedical sciences from Vrije Universiteit Amsterdam in 2012
  • Bsc in Medecine from CUNK/ Centre Universitaire Extension de GOMA in 2003

Training and Certification

  • GMP in 2017 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    French
    Native
    Dutch
    Full Proficiency
    English
    Native

Area / Region

Antwerp, Belgium

Others

Driving License
  • Yes

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