Daksheshkumar Patel

Background

About Daksheshkumar Patel

I hold a Master’s degree in Organic Chemistry with over eleven years of progressive experience in pharmaceutical laboratories, with a strong focus on Quality Management Systems (QMS), regulatory compliance, and GMP operations. Having advanced from entry-level laboratory roles to an Analyst position, I bring both technical analytical expertise and in-depth quality systems knowledge.My professional experience includes active involvement in QMS activities within FDA and cGMP-regulated environments, ensuring full compliance with ICH, USP, and internal quality standards. I have hands-on experience managing and supporting:• Deviation, OOS, and OOT investigations• CAPA management and effectiveness checks• Change control processes• Root cause analysis (RCA)• Risk assessments and impact analysis• SOP drafting, revision, and document control• Audit preparation and regulatory inspection support• Data integrity compliance (ALCOA+ principles)• Training documentation and compliance trackingWith a strong foundation in analytical testing of raw materials, intermediates, stability samples, and finished products, I understand quality systems from both operational and compliance perspectives. This dual expertise enables me to effectively support cross-functional teams including QC, QA, Production, and Regulatory Affairs.I am detail-oriented, process-driven, and committed to continuous improvement. My strengths include clear documentation, strong communication skills, and ensuring that quality systems remain inspection-ready at all times.Currently seeking opportunities in Quality Management Systems (QMS), Quality Assurance (QA), Compliance, and Pharmaceutical Quality Operations roles where I can contribute to maintaining robust, compliant, and efficient quality systems.