Samia Kausar

Background

About Samia Kausar

Have obtained a bachelor’s degree from the University of Toronto in Life Sciences (B.Sc.) and a post-graduate certificate in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College. In terms of my professional background, I have 5 years of experience in the pharmaceutical industry working for Apotex Inc. I have held various roles in departments ranging from regulatory affairs, compliance and operations. Career Accomplishments- Achieved zero production downtime due to prompt implementation of the Change Control Process and to ensure the reliability of supply - Track and present weekly/monthly departmental metrics - Implemented Lean Six Sigma methodologies on documents including Standard Operating Procedures, Forms, Sheets, Master Documents & Global Quality Policies for Richmond Hill Apotex site - Initiate improvements for production safety, quality, reliability and regulatory compliance in a GMP environment - Prepare and/or review 100's of labelling, Patient Information Leaflets and Product Monographs (drug safety updates - both English and French)- Actively involved in the research and development of a roll on analgesic preparation and filed NDS for approval by Health Canada. Now the product is on select pharmacy shelves. Personal Attributes: I have a keen interest in project management, process improvement and optimization, lean manufacturing, and product development. I am a results oriented individual with strong communication, interpersonal, negotiation, decision-making, problem solving, attention-to-detail, time management, presentation and organization skills. I have an ability to manage multiple projects with strict deadlines under minimal supervision, collaborate effectively within a team and grasp and apply new procedures quickly Experience in using software such as SAP, Content 7, Trackwise and Livelink