Fathima Ifthiya Rixzan

Background

About Fathima Ifthiya Rixzan

My former colleagues have been impressed with the industrial expertise that I carry and my critical thinking capacity in the allied field. I have solved numerous processes and product related complicated problems and trained many Seneca and Humber colleges’ interns on Quality and Compliance A highly resourceful and articulate team player who collaborates effectively with all levels of management, staff and clients. Committed to the provision of the highest levels of quality and service excellence. My diverse background in quality and compliance industry ranges from packaging operator to quality and compliance auditor. I have designed scientific study protocols such transportation validation, stability and temperature mapping, drafted vendor quality agreements, conducted root cause analysis for deviations, CAPA and initiated many change controls. I am an expert in Good Manufacturing Practice related documentation reviews to compliance audits. Moreover, I have interacted with 3PL services to provide business continuity plans and navigate them to be compliance with GMP and Golden Standards set by company Quality Management Systems. I am Quality Assurance Personnel with a strong scientific background and over 10 years of field experience in natural health products, pharmaceutical and medical device. Specializing in monitoring product performance through an integrated approach of applicable GMP, Medical Device Standard and Regulatory requirements and process improvement initiatives. I assist companies with their inspections and manage requests from regulatory authorities. My specialties are Product Release, Change Management, Formulating Testing Specifications, Deviations, Root cause analysis, Batch Records Review, Temperature Excursion and Temperature Mapping Studies, GMP inspections, Internal Audit, Supplier Qualification, Annual Product Quality Review, Product Complaints, and Product launch.