Experience

OGEN

• Canada
• Manufacturing
• 1 - 100 Employee

• QAP + Senior PIC

  • Feb 2015 - Present



Endeavor Consulting Group, LLC

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Quality Operation Principal Consultant

  • Jan 2014 - Present

  Quality Operations Principal Consultant, Endeavor CG. Will use experience of pharmaceutical industry to work with life science clients in developing, coordinating and directing quality programs (including Quality Assurance, Quality Control and other related activities) designed to ensure client practices and their respective products and processes complies with their customer requirements, their company policies and procedures as well as meet relevant regulatory agency requirements and Good Manufacturing Practices (GMP). Show less



Banner Pharmacaps

• Director Quality Operation

  • Jul 2008 - Dec 2013

  Director of Quality Operation, Banner Pharmacaps (Canada) Ltd. as an experienced leader with 19 + years of pharmaceutical industry experience holding various positions of increasing responsibilities. Benoit has worked in QC testing environment for the first 8 years of his career and then in Quality Assurance, Quality Control, Auditing, Regulatory, Manufacturing, Products/Process development or redevelopment, and Project Management for the remainder 12 years of his career. He is a well-rounded, direct, level headed, practical no nonsense individual.Key Qualifications and skills:• Quality Assurance, Regulatory Standards and GLP Requirements: (ISO9000 series, Health Canada, US FDA, 21 CFR 51 (GLP regulation), ICH Q8, 9, 10, 21 CFR part 11 (electronic signature), and 111 (Dietary supplements))• Quality Control as it relate to Drugs/Food testing (USP, Food Chemical Codex, BP, etc…)• Root Cause analysis using 5W, Fish bone diagram or others techniques, leading to the identification of the most probable cause and the generation of CAPA(s) to eliminate root cause recurrence. • Extensive experience in internal audits, and external suppliers' audits.• Leadership experience in Quality remediation activities.• Impressive track record of successful customers', and regulators' site inspections - (50+ successful inspections - for over ten years (i.e.: Class A Precursors, Health Canada, FDA, WHO, USP, CFIA, HALAL, etc...).• Effective use of verbal, and written communication to deliver appropriate messages; in the language used at the organization's level being addressed.• Execution and mechanically driven, allows for understanding of manufacturing processes and their capability limits.• Effectively use Project Management for driving a multitude of projects: building expansions, processes/products improvements, new processes implementation, and new products implementation.• Safety minded to ensure congruence of corporation safety core values in Quality practices. Show less

• Manager Quality Assurance

  • Sep 2001 - Jul 2008