Lavina

Quality and regulatory-focused healthcare professional with 5+ years of experience in GxP environments spanning laboratory operations, clinical research, and diagnostics. Strong background in Quality Management Systems (QMS), SOP development, CAPA, deviation management, and regulatory compliance frameworks. Experienced in post-market surveillance support, customer complaint review, safety documentation, and data trending activities.

Proven ability to support regulatory documentation, technical data analysis, and cross-functional compliance initiatives. Seeking to transition into a Regulatory Affairs Specialist role focused on Health Canada submissions, post-market surveillance, and product compliance across multi-category portfolios.

Laboratory Specialist at APL Calgary (2021-12 – Present)

• Ensure compliance with strict regulatory and quality standards through accurate data review, reporting, and traceable document control practices within the EDMS.
• Simultaneously managed multiple documentation and operational compliance projects, ensuring strict timeline adherence for data-driven validation tasks.
• Lead the review, authoring, and updating of internal SOPs and clinical protocols to ensure operational workflows remain fully aligned with evolving quality frameworks.
• Monitor quality metrics, identify performance trends, and escalate compliance or safety risks to leadership while supporting CAPA investigations and deviation tracking.
• Partner with cross-functional operational teams to resolve protocol deviations, handle incidents, and assist in root cause investigations.
• Prepare regulatory-compliant reports, certificates of analysis, and required supporting documentation to ensure continuous audit readiness.

Research Associate at RNA Diagnostics Inc. (2019-01 – 2021-12)

• Developed and maintained GCP-compliant study protocols, informed consent forms, and regulatory amendments for institutional review board submissions and approvals.
• Supported safety reporting, adverse event monitoring, and incident investigations in alignment with ICH guidelines and internal quality systems.
• Conducted risk assessments, data validation activities, and process improvement initiatives across research and product development workflows.
• Performed detailed data trend analysis and systematic screenings of scientific literature to support clinical validation strategies and contribute to overarching CAPA strategies.

Master by Research in Biomedical Science – University of Glasgow

Bachelor of Science in Microbiology – University of Mumbai