Bio-Engineer specialized in Quality Assurance, Quality management, Clinical and Technical Support, with more than 5 years experience in Life sciences sector (Medical devices, Pharmaceutical, ...).
My mission: Assist / Help / Providing counsel & expertise to organizations in their activities.
• Strong academic background, double competencies (Scientific and project management),
• Multidisciplinary experience in engineering, research, consulting and management,
• Multi-sectorial international experience, on various innovative topical projects,
• Polyglot - Ability to work, live and travel abroad as necessary.
Area of expertise: • Quality Assurance, Quality management and Compliance, • Clinical and Technical Support in medical devices sector, • Project Management, Risk Management and process engineering, • Continuous improvement. Recent trainings: Cardiac Rhythm Management – Bradycardia Master Course ISO 13485 – Quality and complaint management Clinical support and Technical aspect in medical devices Project Management and Risk Management Complaint / deviations management • Lean Six Sigma : Yellow belt. • Nederlands (Dutch - Level 2 on going)
Clinical Technical Support Engineer
Since May 2015
LivaNova PLC (Merger between Cyberonics Inc. and Sorin Group) is a medical device manufacturer, developing devices used for cardiac surgery, Neuromodulation and cardiac rhythm management. My missions: Providing clinical and technical support related to VNS Therapy (Neuromodulation) and CRM (Cardiac Rhythm Management), especially in customer experience and technical expertise. - Providing clinical and technical support related to the medical device products (VNS Therapy and CRM), especially in customer experience and technical/scientific support, - Complaint investigations in accordance with Company policy, FDA and international regulations, - Troubleshooting of events with customers and/or commercial teams, - Researches solutions to questions or problems (eg. Therapy system questions, product issues) and provides answers according to labelling, specifications and clinical or technical data, - Training and maintains current knowledge regarding the Therapy programs, products and services, - Provides technical expertise and knowledge in workshops, product demonstrations and during implant surgeries. SKILLS: Medical devices, Healthcare sector, Technical and clinical support, cGMP, Compliance, Complaint management, Medical device reporting to the authorities, Customer orientation and experience, Team Player, Cardiac and Vagal nerve Therapy technology.
Clinical Technical Support Associate
Since August 2013
Cyberonics, Inc. is the leader in device solutions for epilepsy and is committed to consistently delivering innovative and effective solutions for physicians, caregivers and people with epilepsy. Cyberonics’ VNS Therapy® is the only FDA-approved device for the treatment of refractory epilepsy. My missions: Providing clinical and technical support related to VNS Therapy, especially in customer experience and technical support.
Consultant - Project Engineer
April 2012 --- May 2013
ALTEN Belgium is one of the largest Belgian IT / engineering solutions & consulting companies. - Consultant - Project Engineer in Life Sciences business unit. - Participated to the life sciences projects, especially in Pharmaceutical industries, - Worked on ALTEN support activities to ensure that clients receive the highest quality services. ALTEN INTERNAL TRAINING: - Project Management (PMBok) - Risk Management SKILLS: Organization Consulting, Project Management, consultant, Communication Skills, Presentation, Team Player.
Operational bulk support Engineer - Consultant
May 2012 --- January 2013
Operation Bulk Support Engineer (Calibration & Measurement C&M, Environmental Monitoring, Production equipment preparation & Cleaning) at GlaxoSmithKline Vaccines. - Planning and follow up of calibration and measurement (C&M) of GSK Bulk equipments, - Tracking, investigating and monitoring of C&M gaps - Trends (E6) in SAP system, - Deviation handling according to the cGMP regulations and GSK standards, - Deviation investigations leading (Potential product impact, Root cause analysis, actions), - Working with, reporting, discussing and challenging QA operations, production and C&M teams, - Implementation of CAPA Plan and actions to improve support activities, - Training and sensibilization of the operators. GSK INTERNAL TRAINING: - cGMP induction & cGMP de base - Navigation within SAP - Deviation notification management & Deviation notification handling in SAP - CAPA notification management - Producer GMP &Quality monitoring environment reporting - C&M master data and reporting consultation - C&M gaps notification (E6) management. SKILLS: cGMP, Deviation & CAPA management & KPI, Vaccines & Bulk process, Operation Quality Assurance, consultant, SAP, Team Player, Compliance & Regulatory.
Quality (Quality Assurance / Quality Management) Coordinator
January 2011 --- March 2012
"Quality Management System implementation project and routine QA activities". - ISO requirements training to the staff, - Conducted processes audit according to the standards and cGMP regulations, - Gap analysis and CAPA’s implementations, - Development and written Quality manual, SOP’s, procedures and a process map for a service, - Revision of a validation plan, protocols, procedure testing. SKILLS: Quality Management, Change Management, Risk Management, cGMP, ICH, ISO 9001 & ISO 13485, Brainstorming, 5Why’s, 6M, PDCA, Audit, CAPA, Medical devices industry, English.
Quality Assurance and R&D Engineer (Internship)
April 2010 --- November 2010
"Implementation of a Quality and food safety management system (IFS standard)". SKILLS: Quality Management, Risk Assessment, Continuous improvement, ISO 9001, ISO 22000, IFS/BRC standards, HACCP, Audit, PDCA, Customer complaince management, MS Office, SAGE 100, Lotus Note 8, Auto CAD, Organizational Leadership, Team Player, English.
Bioprocess research Engineer (Internship)
September 2008 --- August 2009
THESIS: “Redox state studies of yeast membrane protein in oxidative stress condition”. "Development of a new biotech method for the commercial production of natural flavor compounds". Management of a bioengineering project on natural food flavor compounds. SKILLS: Project Management, Research, Microbiology and biotechnology, Cytomic and proteomic studies, HPLC, TLC, GCMS, Spectroscopy, SDS-Page, Western blot, PCR, Atomic absorption, Dissolution, Research writing, Team player, Organizational leadership, Training, English.
Quality Assurance and Validation Engineer (Internship)
December 2007 --- July 2008
"Quality Control and Quality Assurance in the design and development of a new generic antibiotic drug". SKILLS: Pharmaceutical sector, EU pharmacopeia, Generic drug and Antibiotics formulation, GMP, BPF, ICH, QA Operational, QA review, Quality Management, Risk Management, Continuous improvement, Analytical method validation, 6M, PDCA, cause-and-effect diagram, Audit, Analytical/Research Skills, HPLC, GCMS, Compliance, Team Player.
Quality Control Technician (Internship)
June 2007 --- October 2007
"Quality Control & Quality audits in “Elite Skim” milk powder production process". SKILLS: Food industry, Milk and dairy products technology, Quality control, HACCP, Analytical Skills, Audit, English, Team work.
AdaptabilityAnalytical thinkingWillingness to compromiseService orientedSelf-disciplineTrustSociabilityResponsibilityReaction to stressProblem solvingProactivityOrganizationInterest in knowledgeFlexibilityCuriosityCritical thinkingCoordinationCommunicativeCollaborationStrategic thinkingResult OrientedOptimism
Skills and Expertise
Analytical skills Assure medical quality Create SOPs Interact with physicians Write papersAct as the main line of communication between the sponsor and the investigatorAdverse event reportingAnalyze data/information to determine potential relationships.Aseptic techniquesAssure medical qualityCapture data on source documentscollaborate in research projects at universitiesCollect patient forms and questionnairesCommunicate with investigatorComplete case report form (CRF)Conduct limited data and/or statistical analysis.Conduct research at universitiesCreate standard operating procedure (SOP)Data codingDesign data reporting systemsAnalyze proteinDetermine potential relationshipsDocument employees training requirementsFollow up training programsFollow-up of internal auditsFollow-up of Quality Management System (QMS) processesIdentify risksImplement Key Performance Indicators (KPI's)Implement Quality Management System (QMS)Interact with regulatory stakeholdersLabeling compliance with local regulationsMaintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationOral presentationPrepare internal auditsProvide technical supportQuality control processRegulatory documentationReport deaths to regulatory authoritiesReport non-compliance incidentsReport serious adverse events (SAE)Report technical problemsReview clinical study reportsReview manufacturing documentationReview quality control activitiesSolve problemsTeachingUse laboratory techniquesVerify dataWork under specific instructionsWrite documentsWritten presentation
Master (M.Sc.) in Sciences, Technology and Health in Quality Management & Financial Control. from AgroSup Dijon in 2010
Master (M.Sc.) in Sciences, Technology and Health in Biotechnology - Microbiological Process & Quality from ENSBANA Engineering School - France in 2009
Engineer in Quality Control and Analysis in Biology/Biological Sciences, General from University of Sciences and Technology of Algiers (USTHB) - Algeria in 2008
Training and Certification
Test of English for International Communication - TOEIC in 2010 Certification