Mary Rahmat

Background

About Mary Rahmat

Healthcare - ASQ/CQA guidelines - Project management - ICH/GCP regulations, Health Canada Code of Ethical- Clinical drug development process- Clinical study design, planning, and budget management - Generate/review/revise SOPs based on regulations and industry standards - Worked closely with Research Ethic Board/CTO for regulatory submissions - Strong knowledge of research regulations and guidelines: ICH/GCP guidelines, TCPS II, PHIPA-Declaration of Helsinki, FDA CFR and Health Canada Regulations - Strong knowledge of AATB standards and Health Canada regulations with regards to tissue banking - Knowledge of ISO 9001 (including auditing)- Lean Principles, Process Improvement Pharmaceutical - Strong knowledge in cGMP, GCP, GLP, regulatory affairs, FDA, HPFB regulations and ICH guidelines - Hosted Health Canada, FDA, Internal audit teams - Performed various audits to assure the quality of all operational aspects of the Bioclinical - Department: Bioanalytical Laboratory, Clinical Studies Department, and Pharmacokinetics Unit, operations in the Pharmaceutical sectors. Audited over 50 projects (drugs) annually - Strong understanding of the concepts and requirements for validation of pharmaceutical as well as tissue bank’s facilities, equipment and processes - Skilled in analytical instruments such as HPLC, GC, UV_VIS, IR, as well as Wet Chemistry techniques - Trained on pharmaceutical statistical analysis, analysis of variance (ANOVA), regression analysis, population hypothesis testing, experimental design and control charts