Abdel Malek Fadel
Deviations Specialist @Resilience
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WORK HISTORY
Deviations Specialist @Resilience
Mississauga, ON, CA
Led the initiation, management, and completion of 300+ deviation investigations within international regulatory timelines, contributing to over $100+ million in revenue generation- Facilitated 5+ cross-functional teams monthly to develop investigation plans, utilize advanced root cause analysis tools (6M’s, Ishikawa, 5 Why’s), and implement robust CAPAs to prevent recurrence and enhance operational reliability- Leveraged expertise in Enterprise Management Systems (MVP), PM/CAL activities, and commercial manufacturing processes (Upstream & Downstream) to optimize operational workflows and support project success- Applied in-depth knowledge of cGMP/GDP standards and ALCOA+ principles to ensure precise, compliant deviation closures across global regulatory frameworks (CAN/US/EU/JP), supporting high-quality outcomes in the pharmaceutical and healthcare industry- Drafted and managed Protocols, SOPs, WINs, and Change Management workflows using Veeva, MS Project, and Smartsheet. Demonstrated expertise in compliance documentation and ensured effective project coordination within regulated environments.
EDUCATION
Western University
Bachelor of Arts - BA
ABOUT ABDEL MALEK FADEL
Results-driven Deviations Investigator with expertise in root cause analysis, process optimization, and regulatory compliance within highly regulated industries. Skilled in investigating complex deviations, CAPA development, and ensuring adherence to global quality standards (cGMP, CAN/US/EU/JP). Experienced in cross-functional collaboration, risk assessment, and continuous improvement initiatives that enhance operational efficiency and compliance. Proficient in data-driven problem-solving, stakeholder engagement, and workflow optimization, with a passion for driving quality excellence and regulatory alignment.
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