Profil professionnel
Vue d'ensemble
Expérience
Formation
Compétences
Websites
Languages
Certificats
Volunteering & Community engagement
Informations complémentaires
Chronologie
Generic

Marie Emmanuelle Koffi Kouame

Pharmaceutical Quality and Regulatory Specialist | Public Health-Oriented
Québec

Profil professionnel

Results-driven biopharmaceutical and pharmaceutical development specialist with over 5 years of experience in quality assurance, regulatory compliance, and laboratory analysis. Currently pursuing an MBA in Pharmaceutical Management. Proven track record in leading internal audits, improving SOPs, implementing QMS systems, and training staff. Passionate about public health, global access to medicines, and strengthening healthcare systems through operational excellence and collaborative leadership.

Vue d'ensemble

2
2
years of professional experience
1
1
Certification

Expérience

Results Analyst II – Immunology

Syneos Health
Québec
02.2021 - Actuel
  • Led internal audits and contributed to quality system improvements in compliance with GCP/ICH.
  • Drafted and optimized SOPs; coordinated interdepartmental quality initiatives.
  • Trained new staff on QA procedures and tools, improving team productivity by 20%.
  • Collaborated cross-functionally with operations and regulatory teams for continuous improvement.

Technologist – COVID-19 Response

CISSS Chaudière-Appalaches
Québec
01.2020 - 01.2021
  • Performed microbiological analyses and contributed to emergency response workflows.

Sample Management Specialist

Syneos Health
Québec
01.2019 - 01.2020
  • Managed reception, inventory, and shipping of biological samples under GLP guidelines.
  • Supported QA team in ensuring traceability and process compliance.

Intern – Ministry of Transport

Government of Québec
01.2019
  • Handled official documentation
  • Supported administrative processes.

Formation

MBA - Pharmaceutical Management

Laval University
Quebec, Quebec
01.2024 -

Certificate - Drug Development

Laval University
Quebec, Quebec
01.2023 - 01.2024

B.Sc. - Biopharmaceutical Chemistry

Laval University
Quebec, Quebec
01.2017 - 01.2020

Compétences

  • Project coordination & Team supervision
  • GMP/GxP/ICH-GCP compliance FDA, EMA, Health Canada standards
  • SOP development & process optimization
  • Internal audits CAPA risk analysis
  • Performance indicators (KPI) monitoring
  • Quality systems implementation (QMS, LIMS)
  • Staff training & knowledge transfer
  • Public health engagement & community initiatives
  • Microsoft Office Suite (Advanced)
  • Analytical tools: Watson LIMS, Analyst, JMP, HPLC
  • QMS and Electronic Document Management Systems

Languages

French
Langue maternelle
English
Intermédiaire

Certificats

  • Project Management Foundations, Google (Coursera)
  • Epidemiological Tools for Public Health, Coursera
  • Public Health Training Modules, MSSS, Québec

Volunteering & Community engagement

  • Director, Women's Section, UFUS Canada
  • Volunteer Organizer, Girls' Education Fundraiser, Québec
  • Literary Club Communications Lead, Abidjan
  • Event Decor & Logistics, WestAf Fashion Show, Québec

Informations complémentaires

  • Traveling: Passionate about discovering new cultures and healthcare systems
  • Cooking: Enjoy exploring culinary traditions from various regions
  • Music: Practice and appreciation of diverse musical genres
  • Sports: Active in cardio-based sports for physical and mental well-being

Chronologie

MBA - Pharmaceutical Management

Laval University
01.2024 -

Certificate - Drug Development

Laval University
01.2023 - 01.2024

Results Analyst II – Immunology

Syneos Health
02.2021 - Actuel

Technologist – COVID-19 Response

CISSS Chaudière-Appalaches
01.2020 - 01.2021

Sample Management Specialist

Syneos Health
01.2019 - 01.2020

Intern – Ministry of Transport

Government of Québec
01.2019

B.Sc. - Biopharmaceutical Chemistry

Laval University
01.2017 - 01.2020

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Marie Emmanuelle Koffi KouamePharmaceutical Quality and Regulatory Specialist | Public Health-Oriented