Sunali Shah

Quality Management Systems (QMS) and Compliance Professional with ISO Auditor certification. Diverse work experience within the industry in QA, Microbiology laboratory, Regulatory, Compliance and Auditor roles. Proven track record of effectively monitoring and managing risks related to operations and products by developing and implementing strategies to align with business needs.

Supported change management activities within Quality systems by integrating different divisions, managing training programs.

• Extensive experience interpreting regulations such as CFR 21, GMP, GLP, GCP, Health Canada, FDA, MDR, and IVDR
• Developed, implemented, and maintained Quality Management Systems to include procedures, documentation, field action plans, calibration, validation plans, change control process, Risk management process
• Prepared site license applications for importing active pharmaceutical ingredients and finished dosage forms for submission to Health Canada
• Led communication across local and global teams to implement improved processes for compliance
• Analyzed risks and requirements to develop practical solutions for complex problems
• Excellent strategic skills involving planning for long-term goals, while exhibiting tactical skills to achieve short-term objectives. Balancing both ensures progress toward immediate targets without losing sight of broader, future aims

Masters in Microbiology

Quality & Regulatory affairs in Pharmaceutical Industry diploma