Shaivi Saini
Documentation Control Specialist @Best Theratronics
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WORK HISTORY
Documentation Control Specialist @Best Theratronics
Ottawa, ON, CA
Maintained the master procedure database and spreadsheet• Submitted fieldwork notifications to state regulators (US) and Canadian authorities• Handled regulatory reporting of X-ray activities on a monthly basis to state-level radiological authorities across the United States• Maintained repository of all electronic procedures including controls/issues numbering, keeping standard templates for all procedures and the preparation of all draft procedures, and ensuring all other processes such as approvals, signatures, notifications, security are maintained• Responsible for the full lifecycle management of QA Library documents, including creation, revision, approval, distribution, and archiving• Ensured timely renewals for Reciprocity and X-Ray licenses• Kept training database and training records up-to-date for the Quality Assurance, Manufacturing and Engineering departments• Assisted in Quality System Audits (ISO, FDA, Health Canada, CNSC, USNCR), Health Canada applications such as MDEL/MDL and Excol• Led onboarding compliance training for new hires, promoting understanding of regulatory and internal procedures• Conducted internal audits for manufacturing processes• Coordinated comprehensive external documentation lists to ensure accuracy and relevance• Updated monthly quality progress reports to reflect the status of deviations, design changes, and CAPAs, ensuring accurate tracking and timely reporting• Updated yearly product safety update reports for all product lines, including Gammacell, Raycell, Equinox, Mobile MOSFETs, and portable dosimeters• Sent out monthly and yearly reminders ensuring compliance with various standards• Set up triennial audiometric testing for production floor staff• Maintained office supplies for the compliance team along with health and safety supplies • Responsible for facilitating routine third-party service operations, including hygiene management through Citron and uniform services through Cintas
EDUCATION
Goswami Ganesh Dutta SD College
Master's in Applied Chemistry, Pharmaceuticals
Fanshawe College
Regulatory Affairs and Quality Operations, Health Sciences
MCM DAV College - India
Bachelor of Science, Medical
ABOUT SHAIVI SAINI
With a strong academic foundation in regulatory affairs, quality operations, and applied chemistry, I am passionate about ensuring compliance and upholding industry standards in pharmaceuticals, food, and medical devices. My experience in document control, regulatory compliance, and quality assurance has equipped me with the skills to navigate complex regulations, manage documentation, and support audits.Beyond my professional and academic experiences, I have been actively involved in student leadership and volunteer initiatives as well. These roles have strengthened my leadership, communication, and organizational skills, allowing me to advocate for students, support events, and foster an inclusive environment.I thrive in fast-paced environments, bringing strong analytical, problem-solving, and communication skills to every challenge. Whether collaborating in teams, leading initiatives, or streamlining processes, I am committed to excellence and continuous learning. Excited to connect with like-minded professionals and explore opportunities in regulatory affairs and quality compliance in Canada!
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