Umaina Haroon Email & Phone Number

Toronto

Oakville, Ontario

Regulatory Affairs Submissions

Mississauga

• Supported senior management with execution of compliance activities, responses to quality alerts and ongoing investigations of product incidents and recalls• Authorized Standard Operating Procedures (“SOP’s”) to be compliant with pharmacopoeia requirements and provided recommendations to scientists on manufacturing best practices• Assisted in preparing Planned Change Notification reports and summaries related to microbiology testing procedures• Represented Quality Control (“QC”) microbiology lab during Health Canada audits and coordinated the documents gathering exercise with internal stakeholders• Led root cause analysis to identify corrective and preventative actions associated with QC testing• Actively participated in performance management projects such as KAIZEN and LIFT to redesign and modify laboratory procedures to improve efficiency• Conducted continuous gap analysis and risk assessments on manufacturing media and quality control tests• Consistently liaised with internal business partners such as Business Planners, QA and Engineering teams to ensure compliance on various deliverables• Executed transactions in SAP system to create self inspection tasks, close CAPA tasks and schedule product test dates • Performed daily activities related to quality control tests on media, water testing and project management initiatives• Proactively sought opportunities to train and mentor other members of the team as part of the Buddy Trainer program at GSK• Effectively utilized multiple systems such as SAP and LIFT for purpose of submitting results and reports for marketed products

Post-Graduate Diploma, Pharmaceutical Regulatory Affairs

•Market awareness of the regulatory landscape in the U.S and Canada, including working knowledge and experience with the Food & Drugs Act.

Honours Bachelor Of Science, Biomedical Science