Devyani Patel

Dynamic and results-oriented professional with a proven track record in quality assurance and compliance within regulated industries. Experienced in driving effective quality planning, improvement, evaluation, and prevention to meet or exceed customer requirements. Eager to contribute to the deployment of quality functions throughout the product manufacturing cycle and ensure adherence to quality management systems. Dedicated to facilitating continual improvement activities and driving excellence in product quality and performance in manufacturing industry." 

• Prepared documentation for all aspects of the Computer Systems Validation (CSV) lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11.
• Experience with environmental regulations and manufacturing processes e.g., GMP, cGMP, CAPA's and Validations. 
• Reviewed materials and supplies upon receipt, ensuring adherence to product specifications and requirements.
• Reviewed/Validated fixes, documentations (user manuals, installation instructions) for the MES against GMPs.

• Employed robust manufacturing quality processes and tools such as FMEA, Risk Assessment, and Root Cause Analysis in the comprehensive evaluation of final assembly products.
• Ensure product drawings and specifications as per the customer requirements.
• Perform electrical testing techniques such as connectivity test, load test, insulation resistance test to ensure proper functionality of electrical circuits and assemblies as Quality check procedure.
• Maintained an organized record of electrical testing results, leveraging tools like FMEA and Root Cause Analysis, and prepared meticulous data documentation for future analysis. This proactive approach aimed at continuous improvement, significantly reducing the likelihood of future issues with the product.