Ronak Patel

Background

About Ronak Patel

As a Regulatory Affairs & Quality Assurance professional with extensive experience in the pharmaceutical industry, I have a proven track record of ensuring compliance with regulatory requirements and maintaining high standards of quality. My current role as a Regulatory Affairs & Quality Assurance Associate at Platform Life Sciences involves facilitating and driving the risk management process, conducting internal and site audits, preparing audit reports, and managing responses to audits. I also provide support with the investigation of quality issues and interact with authors/reviewers and subject matter experts concerning the delivery of regulatory documents required for regulatory submissions. • In my previous role as a Quality Assurance Coordinator at Bold Growth Inc, I provided technical assistance to various departments and assisted with identifying compliance and quality assurance requirements while fulfilling company objectives and production deadlines. I also participated in developing and maintaining quality assurance and regulatory compliance programs and conducted internal and vendor audits. • As a Sr. Officer – Quality Assurance at Intas Pharmaceuticals Ltd, I provided support for Quality Assurance activities related to manufacturing operations and the release of finished products. I also led quality projects and initiatives and support activities in Quality Assurance, including participation in validation activities, reviews, and approvals of GMP Master Documentation, internal and external auditing programs, employee training, and incident investigation. • My qualifications include a Bachelor of Pharmacy and a Master of Pharmacy in Pharmaceutics, as well as a post-graduate diploma in Drug Regulatory Affairs (PGDRA) and certifications in Six Sigma – Yellow Belt and Green Belt. I possess skills in qualification and Computer System Validation, SAP, Microsoft Office, LIMS, Adobe Acrobat, quality auditing, training management, eCTD, GMP and GCP, eQMS, vendor management and qualification, quality risk management, QA-QC, QBD and QTL, and more. • Throughout my career, I have been committed to maintaining the highest standards of quality and compliance, and I am always looking for opportunities to further develop my skills and knowledge. If you are looking for a dedicated and knowledgeable Regulatory Affairs & Quality Assurance professional, please don't hesitate to reach out to me.