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Rama P
Six Sigma Lean Black Belt Professional (LBBP) Control of Validation ISO 13485, MDSAP, FDA, GMP, HACCP and SQF.
Professional Background
Rama P is a dedicated professional with extensive experience in the quality assurance and regulatory affairs sector, specifically within the medical devices and food industry. With a strong foundation in microbiology and quality control, Rama has excelled in various roles, demonstrating superior problem-solving skills and a meticulous attention to detail. As a Quality Manager at Walsh Medical Devices Inc., Rama was responsible for overseeing the quality management systems and ensuring compliance with relevant regulatory standards such as Health Canada Regulation, MDSAP, FDA, ISO 17025, 13485, 14000, 18001, 9001 (IMS), GMP, HACCP, and SQF.
Having formally held positions such as Quality Assurance Specialist at G. Brandt Meat Packers Ltd. and Quality Assurance Technician at Maple Lodge Farms, Rama has cultivated a comprehensive knowledge of internal auditing and the creation of outcome reports. This experience has allowed Rama to undertake continual process and procedural improvement, a key aspect of quality assurance that helps organizations optimize their operations and maintain high standards.
Rama’s professional journey has also included valuable contributions to Medtronic, where she worked in a specialized capacity within the cryo domain in Montreal. Her hands-on experience as a Microbiology Laboratory Technician at both Maxxam Analytics and Chizar Laboratory has equipped her with practical skills and insights that enhance her quality control capabilities.
In addition to her technical skills, Rama possesses excellent communication abilities, which she has adapted to effectively meet the needs of diverse teams and stakeholders. Her bilingual proficiency in English and French enables her to operate seamlessly in multicultural environments, further enhancing her effectiveness as a collaborator and leader in quality assurance initiatives.
Education and Achievements
Rama’s educational background is diverse and supports her extensive professional expertise. She holds a Bachelor's degree in Microbiology from Azad University (IAU), where she developed a solid scientific foundation. This was complemented by her further studies in Medical Devices Quality Assurance & Regulatory Affairs at Sheridan College, where she acquired a robust understanding of the regulatory landscape governing medical devices.
In addition to her formal qualifications, Rama has also pursued language studies at the Université de Montréal, honing her French skills to foster effective communication in bilingual settings.
Rama’s commitment to professional growth and continuous improvement is evident in her ability to utilize tools such as MS Office efficiently, contributing to her exceptional organizational and time management skills. She has a proven track record of conducting internal audits and generating insightful outcome reports that drive strategic decision-making and operational enhancements.
Achievements
Throughout her career, Rama has made significant strides in advancing quality assurance practices within the organizations she has served. Some of her notable achievements include:
- Successfully managing and optimizing quality control systems at Walsh Medical Devices Inc., ensuring compliance with an array of regulatory standards, resulting in sustained organizational excellence.
- Leading internal auditing processes that have effectively identified opportunities for procedural improvement, positively impacting overall operational efficiency.
- Collaborating with diverse teams across various manufacturing environments, utilizing adaptive communication methods that cater to different audiences, and reinforcing a culture of quality and compliance.
- Completing various significant projects that demanded meticulous attention to detail and adherence to stringent regulatory frameworks, all of which underscore her capability to maintain high-quality standards.
- Actively engaging in volunteer work at the Hôpital général de Montréal, which reflects her commitment to giving back to the community and fostering goodwill through her professional skill set.