Mohamed-Naourine Yakhou
Quality/Continuous Improvement Engineer
Evians Les Bains
Profil professionnel
Quality engineer with extensive experience in the pharmaceutical and cosmetic sectors. Having worked with market leaders such as GSK, L'Oréal, Sanofi, and Merck, I specialize in managing production deviations, optimizing processes, and ensuring regulatory compliance. With expertise in collaborative project management and handling nonconformities, I focus on continuous improvement and risk analysis.
Vue d'ensemble
6
6
years of professional experience
Expérience
Industrial Quality & Compliance Specialist
Merck
Vevey
01.2025 - Actuel
- Ensure compliance with Merck industry regulations (GMP, ISO standards) in maintenance activities.
- Manage and investigate maintenance-related deviations, ensuring thorough root cause analysis and timely resolution.
- Develop and implement corrective and preventive actions (CAPA) to address deviations in maintenance processes.
- Collaborate with cross-functional teams (Maintenance, Quality, Engineering, Production) to ensure compliance across operations.
- Perform risk assessments to evaluate the impact of maintenance deviations on equipment reliability and product quality.
- Prepare and present detailed deviation reports for audits and regulatory inspections.
- Monitor and optimize maintenance compliance processes to improve equipment performance and reduce downtime.
- Ensure accurate documentation of all maintenance and deviation management activities per regulatory requirements.
- Lead continuous improvement initiatives to enhance compliance in maintenance systems and prevent future deviations.
Sample Inventory Manager
Sanofi
Marcy-l'Étoile
12.2024 - 01.2025
- As the Sample Inventory Manager for the Quality Control archives, my role involved overseeing the physical inventory of samples stored in freezers and cold rooms, ensuring their compliance with the computerized inventory system (LIMS).
- Developed a protocol for conducting inventory, minimizing impact on samples and their storage.
- Supervised the inventory process, coordinating with the team to ensure traceability and resolve discrepancies between physical and computerized inventories.
- Managed discrepancies and addressed quality events related to inventory issues.
- Proposed solutions for managing temperature-controlled units during on-call periods and optimized sample management protocols based on risk analysis and biosafety criteria.
- Supervised the use of LIMS and Veeva Vault tools, ensuring their proper functioning and compliance with regulatory requirements.
- Ensured mission compliance with GMP, cGMP, and other specific requirements of Sanofi Pasteur.
QA
Sanofi
Marcy-l'Étoile
10.2024 - 12.2024
- QA - My role in Quality Assurance (QA) dedicated to Change Control is to ensure the proper management of changes to processes, products, equipment, or systems within a pharmaceutical organization.
- Assess the relevance and compliance of proposed changes.
- Oversee the entire lifecycle of a Change Control, from initiation to closure, ensuring adherence to regulatory and internal requirements.
- Ensure proper documentation for each change to support audits and inspections.
- Operational Quality Support in Various Affected Areas to Ensure Process Fluidity: Quality Control, Qualification and Validation (equipment, processes), MSAT (Manufacturing Sciences and Technology), Physico-chemical, microbiological, and virological analyses, Logistics and supply chain.
- Contribute to the continuous improvement of supplier practices.
Continuous Improvement Engineer
GSK
Wavre
09.2022 - 10.2024
- Continuous Improvement Engineer - As the responsible for managing deviations on-site, my role is essential in ensuring the compliance of manufacturing processes.
- Ensure compliance with current regulations to guarantee operational conformity and the validity of results.
- Co-lead projects and provide technical support to production teams.
- Handle deviations related to E/M, production processes, metrology, and production equipment (maintenance) for 4 MPUs involved in the production of 4 different vaccines.
- Draft detailed reports in SAP, illustrating achieved results and analyzing the root causes of deviations.
- Conduct investigations, including impact assessments, recurrence evaluations, and root cause analysis of issues (using methods such as 6M, human error analysis, interviews, 5-WHY, and DMAIC).
- Collaborate with various departments, including QC (OOS issues), production, maintenance, and supply chain (supplier investigations).
- Implement corrective and preventive actions (CAPA), change controls, and remediation actions to resolve issues.
- Continuously improve procedures (batch records, checklists) to enhance performance and reduce costs.
- Results: Managed and resolved over 140 deviations of minor/major criticality levels.
Quality Engineer
L'Oréal
Caudry
09.2020 - 02.2022
- Quality Engineer - My role was to ensure cleaning and disinfection methods to support production on tanks and production lines.
- Conducted analyses using equipment requiring appropriate qualification, such as TOC meters and gas chromatography.
- Authored and updated cleaning and disinfection validation dossiers.
- Monitored cleaning and disinfection validations for manufacturing equipment (tanks).
- Led a collaborative project with various plant departments (process, production, logistics) to track equipment cleaning and disinfection.
- Optimized cleaning and disinfection operating procedures.
- Addressed non-conformities with short- and long-term solutions for disinfection processes.
- Performed swabbing tests and microbiological/physicochemical analyses (thermal probes, swab sampling) to qualify disinfection processes.
- Compiled results and integrated them into disinfection qualification dossiers for validation.
- Established and monitored KPIs.
- Inspected finished products and raw materials (cytometry, SAP, conductivity).
- Interpreted P&ID diagrams.
- Conducted risk analyses to identify critical points in manufacturing tanks and packaging lines.
- Authored disinfection and washing procedures.
- Maintained manufacturing tank components.
- Achievements: Revamped a disinfection procedure for a manufacturing tank that did not meet L'Oréal disinfection standards: modified the transfer line between the tank and the melter by installing a micrometric screw, reducing steam transfer time between the two components.
- Changed the maintenance routine for a manufacturing tank prone to Gram-negative Bacillus contamination: implemented manual disassembly and washing of spray balls (high-flow circular water injectors) monthly instead of annually, achieving zero contamination thereafter.
- Replaced the cleaning program automation system and created a cleaning recipe that included suction pipes, enabling integrated circulation cleaning with the tank.
- Improved KPIs from 0% to 32% across the site, accounting for vacation and technical issues.
Logistics Manager
Auchan
Saint-Étienne
01.2019 - 01.2020
- Logistics Manager - My role was to lead a team of 10 collaborators to coordinate logistical flows, optimize operational performance, manage inventory, and maintain relationships with service providers, while ensuring continuous process improvement and staff training.
- Led a team of 10 employees: developed work schedules, monitored performance indicators (KPIs), and implemented continuous improvement plans.
- Trained and raised team awareness on safety standards, hygiene, and operational best practices.
- Designed and deployed a recruitment plan: participated in sourcing, onboarding, and training of new team members.
- Coordinated inbound and outbound goods flows: optimized processes for receiving, storing, and shipping.
- Oversaw order preparations, ensuring compliance with specifications and client requirements.
- Managed relationships with transport service providers: adjusted transport plans to accommodate demand fluctuations and operational constraints.
- Planned inventory needs: analyzed restocking requirements based on sales forecasts and market demand.
- Implemented and monitored corrective actions to optimize operational performance and achieve strategic objectives.
- Streamlined work procedures through continuous improvement approaches (Lean Management, 5S, Kaizen, etc.).
Formation
Neurosciences -
Strasbourg
Ingénierie de la Santé -
Saint-Étienne
Licence en Biologie et Physiologie -
Université de Strasbourg
Compétences
BPF/GMP
UPSTREAM/DOWNSTREAM
ANOMALIES GESTION
OPERATIONAL QUALITY
PROCESS VALIDATION/QUALIFICATION
GEMBA
CAPA
SAP
VEEVA
DMAIC
6M
Languages
French
English
INTERESTS
- Travel
- Writing
- Reading (Thriller, Crime)
- Cinema
- Weightlifting
- Boxing
Chronologie
Industrial Quality & Compliance Specialist
Merck
01.2025 - Actuel
Sample Inventory Manager
Sanofi
12.2024 - 01.2025
QA
Sanofi
10.2024 - 12.2024
Continuous Improvement Engineer
GSK
09.2022 - 10.2024
Quality Engineer
L'Oréal
09.2020 - 02.2022
Logistics Manager
Auchan
01.2019 - 01.2020
Neurosciences -
Strasbourg
Ingénierie de la Santé -
Saint-Étienne
Licence en Biologie et Physiologie -
Université de Strasbourg
Profils similaires
Casandra L Santiago-NievesCasandra L Santiago-Nieves
IPT/Shop Floor Controller à MerckIPT/Shop Floor Controller à Merck
Kushal PalliKushal Palli
Team Lead à MerckTeam Lead à Merck
Jessica BakerJessica Baker
Executive Hospital Specialty Representative à MerckExecutive Hospital Specialty Representative à Merck
Avery PruittAvery Pruitt
Operations Technician à MerckOperations Technician à Merck
Vincent MEARVincent MEAR
Technico-commercial à COULEUR FEU (Vendeur et installateur d'appareils de chauffage bois)Technico-commercial à COULEUR FEU (Vendeur et installateur d'appareils de chauffage bois)