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Hassan Abdirizak Operations Specialist
Profile

Project-oriented regulatory professional with experience supporting regulated manufacturing, quality systems, and compliance programs in highly controlled environments. Proven ability to coordinate cross-functional stakeholders, manage documentation frameworks, author and implement SOPs, and support regulatory readiness in alignment with international standards (GMP, GLP, GDP). Brings strong technical literacy, process discipline, and execution rigour suited to standards development, regulatory implementation, and quality system projects.

Work Experience

Operations Coordinator

MIST
12/2024 | Mogadishu, Somalia
  • •Coordinate day-to-day quality control and logistics operations, supporting delivery of services aligned with applicable standards.
  • •Advance continuous improvement efforts in quality control, compliance, and supply chain efficiency across East African markets.

    • Senior Technician, Production

    Eli Lilly
    01/2023 – 10/2024 | Toronto, ON
  • •Supported cGMP-regulated production programs by executing and maintaining compliance with approved procedures, batch records, and quality documentation systems.
  • •Ensured operational alignment with regulatory expectations through strict adherence to SOPs, controlled documentation, and data integrity principles (ALCOA+).
  • •Identified, documented, and supported resolution of deviations and non-conformances, working with Quality Assurance to implement corrective and preventive actions (CAPAs).
  • •Coordinated with QA, QC, Maintenance, and HSE stakeholders to maintain inspection readiness and operational compliance across production activities.
  • •Contributed to continuous improvement initiatives by providing operational feedback on procedures, risk controls, and process robustness.
  • •Participated in internal audits, compliance reviews, and documentation updates supporting regulatory oversight and quality governance.

    • Upstream Production Specialist

    Sanofi
    01/2022 – 12/2022 | Toronto, ON
  • •Supported global clinical manufacturing programs operating under GMP regulations, contributing to standardized processes and regulatory-aligned workflows.
  • •Authored, reviewed, and updated Standard Operating Procedures (SOPs) to reflect evolving regulatory and organizational requirements.
  • •Prepared and co-signed GMP documentation and authored incident and deviation reports, supporting root cause analysis and quality system improvements.
  • •Collaborated with Quality and HSE teams to assess and approve new equipment and workflows against established regulatory and safety standards.
    • Skills
    Regulatory and Quality Systems — Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) | Regulatory Compliance & Inspection Readiness | SOP Development, Review, and Lifecycle Management | Deviation, Non-Conformance, and CAPA Management | Documentation Governance & Data Integrity (ALCOA+)
    Project & Program Execution — Cross-Functional Coordination (Operations, QA, QC, HSE) | Regulatory Implementation & Process Standardization | Training of New Staff in Relevant Procedures | Change Control & Procedural Updates | Stakeholder Communication & Technical Reporting
    Education

    Lighthouse Labs

    Diploma: Full-Stack Web Development
    06/2023 – 09/2023 | Toronto, ON

    McGill University

    Master of Science in Chemistry
    09/2016 – 02/2020 | Montreal, QC

    American University of Sharjah

    Bachelor of Science in Chemistry
    09/2012 – 06/2016 | Sharjah, UAE