Mansura M.
Manager (Quality, Gmp Support) @Cpdc Centre For Probe Development And Commercialization
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WORK HISTORY
Manager (Quality, Gmp Support) @Cpdc Centre For Probe Development And Commercialization
Hamilton, ON, CA
Establish an efficient Quality Management System; support in developing and improving QMS as per regulations- Develop and maintain document control systems as per regulatory expectations- Perform compliance review of GMP and all related documents- Prepare, lead, and deliver GMP training to internal and external stakeholders- Support in technology transfer and validation activities- Manage and execute vendor qualifications and client audits to help ensure inspection readiness.
EDUCATION
American Society for Quality (ASQ)
Certification, Certified Quality Auditor
University of Toronto
Honors Bachelor of Science, Specialized in Biology with Minor in Mathematics
Seneca Polytechnic
College Graduate Certificate, Pharmaceutical Regulatory Affairs And Quality Operations
Seneca Polytechnic
Ontario College Diploma, Chemical Laboratory Technician
SKILLS
ABOUT MANSURA M.
Experience: o Over 10 years of pharmaceutical/radiopharmaceutical work experience. o Over 8 years of management experience.Education: o Completed Honors BSc from University of Toronto in Biology and Mathematics. o Completed a Diploma in ‘Chemical Laboratory Technician’ from Seneca College. o Completed College Graduate Certificate in ‘Pharmaceutical Regulatory Affairs and Quality Operations’ with high honors from Seneca College. o Completed ‘Quality Auditor’ certification from American Society for Quality (ASQ).Interpersonal and Intrapersonal Skills: o Highly skilled in GMP, pharmaceutical quality of Microbiology/Sterility Assurance, and Chemical Laboratory work. o Highly skilled in pharmaceutical quality assurance and regulations from Health Canada and FDA.o Highly skilled in leadership, audit, training, and problem solving with above average behavioral competencies. Excellent client-facing skills.o Highly organized, adaptable, detail oriented, and goal oriented. Self-motivated and strive to meet objectives, deliver high quality work even under pressure, and take pride in meeting deadlines consistently.o Highly driven and skilled for continuous improvements in quality culture utilizing quality KPI and internal audit programs while handling multiple/competing priorities concurrently with excellent resource management and teamwork skills.
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