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.
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
Scientist TraineeJanuary 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
Assistant ScientistFebruary 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.
ReceptionistJuly 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
researcherOctober 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).
Analytical thinkingAdaptabilityAuthenticityFlexibilityInterest in knowledge
Skills and Expertise
Analytical skillsAssemble regulatory applicationsBiomarker ResearchCell cultureChemistry Manufacturing and Controls (CMC) activitiesCollaborate with principal investigatorCollect data
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