Redi Taddese

Experience

• 

  University of Toronto

  Sept 2010 - Mar 2016

  My project focused on determining the functional role of a domain of a bacterial transporter whose homologs in mammals are known to be associated with several pathologies.

  • Research Associate

    Jul 2013 - Mar 2016

  • Graduate Student Researcher

    Sept 2010 - Jun 2013
• 

  Therapure Biopharma Inc

  Mar 2016 - Aug 2018

  QC Analyst

  Prepare client or compendia test methods used for in-process and release testing of QC samples. Perform quality control review of GMP documentations to ensure compliance with applicable US, Canadian or European regulations.Analyze in-process, release and stability samples as per US Pharmacopeia, European Pharmacopeia or client specificationsPrepare and review IQ/OQ/PQ protocols and reports for QC instrument qualifications.Participate in test method feasibility trials, method transfer and qualification studies. Liaise with project teams during OOS, test method troubleshooting and deviation investigations to analyze data and arrive at evidence-based root-cause. Show less

• 

  Q&C Services

  Aug 2018 - Apr 2024

  Retained as quality lead at a multinational pharmaceutical company and acted as a primary liaison between client and third-party service providerLed Health Canada and FDA remediation projects by completing corrective actions in accordance with committed schedules. CAPAs were inspected and accepted by Health Canada without critical or major findingsManaged quality backlog projects to reduce APQR and internal audit backlogs for fabricators and importers, completing 131 APQR commitments within 6 months. Completed self-inspection of 12 quality systems within 4 months and issued audit reports within 10 days of each auditPerformed Health Canada GMP evidence audit of a foreign site fabricator to support establishment license (DEL) application, leading to DEL renewalProvided quality assurance support to two of the largest Canadian importers/distributors to disposition over 50 drug and natural health product batches monthlyLed a team of auditors to complete self-inspection of an international manufacturer at multiple sites. Ensured completion of over 15 system audits at each site, managed corrective action responses and provided audit reports within scheduled timelinePerformed GMP Gap Analysis of domestic and foreign site fabricator and testing laboratory to assess compliance with Health Canada GMPsDeveloped training materials and delivered training to multi-functional membersDeveloped preventive control plan (PCP) to support Safe Food for Canadian Regulations (SFCR) license application Show less Project Highlights: Disposition over 50 drug and natural health product batches monthly for leading Canadian importers/distributors Perform GMP gap assessment of foreign site fabricator, Canadian manufacturer, co-packager and testing laboratoryProvide Quality Assurance support in preparation for regulatory inspectionsBackfill quality roles to support manufacturers and importers Supported Health Canada remediation projects by completing corrective actions in accordance with Health Canada commitment schedule Show less

  • Project Manager

    Sept 2022 - Apr 2024

  • Senior Consultant

    Aug 2021 - Sept 2022

  • Lead Consultant

    Jul 2019 - Aug 2021

  • Associate Consultant

    Aug 2018 - Jul 2019
• 

  Johnson & Johnson

  Apr 2024 - now

  Sr. Operations Manager, JLABS @ Toronto

  Lead all aspects of the JLABS facilities at JLABS @ Toronto and overall site management including accountability for regulatory compliance, security, budget development and management, customer relationship management and administration of agreements and amendments.