About sucheta solanki:
Ambitious Quality Assurance professional with a passion for Regulatory affairs in the industrial world. Motivated, curious, detail-oriented, and easily adaptable to new technology and processes.
I have a strong background in science, with a Masters in Biochemistry from and currently completing a post-grad diploma certificate in Regulatory Affairs and Quality Operations from Seneca College.
I am passionate about bringing innovative new drugs to market by improving patient's quality of life by ensuring the product is safe, effective, and high-quality. I am actively seeking opportunities in Quality Assurance or Regulatory Affaris in the pharmaceutical or medical device sector.
Experience
I am a professional with 8 years of experience in the medical diagnostic device and cannabis industries and have passionately worked in quality assurance and quality control of products. Most recently worked for an API manufacturer and has a track record of success in managing quality systems. Sound knowledge of regulatory guidelines, including those of Health Canada, ICH and FDA, along with other legislation imposed by Health Canada and GMP
Education
I am soon to be a Regulatory Affairs postgraduate (2024) with a passion for understanding the global regulatory requirements, guidelines, and industry best practices in the development and commercialization of innovative drugs, biologics, and natural health products in the health industry. Have a Master’s in Biochemistry with strong multi-disciplinary skills and background. Significant analysis and strategic thinking skills for assessment, evaluation, research-oriented studies, and as a quality expert. I gained several years of lab-based research experience focusing on new product development adhering to the company's mission and requirements and basic life science research to elucidate the role of nutraceutical molecules in the treatment and cure of diabetes.
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