Alexandre has extensive experience in pharmaceutical production including injectable products. His work experiences in global companies and developing biotechs have enabled him to acquire a variety of skills:Pharmaceutical & Industry standards: GMP/GLP, FDA, ISO, EMA, Health Canada, ICH, PDA, USP-NF, HACCP, etc.Over 12 years of experience under standardized practicesAseptic Production & Sterility Assurance: Sterility Assurance Level guidance authorIn charge of designing and executing Aseptic Process SimulationsTrending of contaminants in cleanroomsReview of gowning, decontamination, cleaning and sterilization practicesCleanroom design and qualificationProduction Unit Management: Commercial experience in a plant producing up to 2M filled vials/weekManagement of multiple operating unitsCAPEX and OPEX planning and management Experienced in a syndicated workplaceProject Management: Production lead for clinical studies: Core Team member / subteam leaderImplementation of a new Production Scale-up for the Pilot UnitDesign and Qualification of a new vial filling lineQuality System: Experienced Lead InvestigatorCAPA determination and managementChange Control management and approval for Production or QA UnitRisk Assessments: Experienced in various risk assessment method (FTA, FMEA, HAZOP, etc.)Performed risk assessment for Production, QA, Maintenance Qualification and Validation: Qualification and validation of equipment as author, executor or approverValidation strategy on various topics: Cleaning, sterilization, irradiation, filtration, aseptic simulation, Purified water, Clean air, etc.Audits: Supplier Audit as Company representative and Subject Matter ExpertSubject Matter Expert during FDA, Health Canada or other auditsRegulatory Submissions:Participation to multiple Clinical phases submissions as Production Expert
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