Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor Email and Phone Number
➥I am an influential and experienced professional in quality assurance and regulatory compliance with a wealth of expertise in overseeing and strategizing quality assurance, risk, and compliance management operations across diverse and ever-changing global settings. Additionally, I demonstrate a proven track record of success in overseeing the assessment and enhancement of service quality, ensuring rigorous compliance with regulatory authorities, and managing quality evaluation and enhancement initiatives.➥My background includes ensuring the quality of products and procedures by instituting and enforcing quality benchmarks, while also executing ongoing improvement and corrective measures to elevate the effectiveness of quality assurance endeavors. Additionally, I execute on challenges and maintain a forward-thinking, entrepreneurial mindset aligned with the enterprise vision.➥I am proficient at conducting root cause analyses, driving process improvement, and monitoring performance to maximize effectiveness. A results-driven executive ensuring products, services, and operations consistently meet or exceed established quality standards and comply with regulatory requirements.
Fda Geek
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Founder & CeoFda Geek May 2023 - PresentHarrisburg, Pennsylvania, United StatesHere, I provide exceptional leadership to support diverse clients and enhance quality and compliance. Additionally, I utilize extensive expertise to formulate quality policies, procedures, and strategies to drive the organization forward.➥Identifies and collaborates with cross-functional stakeholders to address the root causes of quality issues, ensuring comprehensive data capture and audit review processes, and maintaining compliance with federal, state, and local regulations. ➥Oversees high-performing cross-functional teams, including professionals in quality assurance, compliance, privacy, as well as project managers, consultants, investigators, and team leads. ➥Offers valuable insights and guidance on a wide array of quality assurance and compliance matters, encompassing regulatory requirements, change control management, investigations, post-market surveillance, risk analysis, supplier quality management, data integrity, reporting, process validation, project management, quality agreements, and more. -
Co-FounderPal Management Consulting Llc Mar 2015 - PresentHarrisburg, Pennsylvania AreaHere, I provide exceptional leadership to support diverse clients and enhance quality and compliance. Additionally, I utilize extensive expertise to formulate quality policies, procedures, and strategies to drive the organization forward.➥Identifies and collaborates with cross-functional stakeholders to address the root causes of quality issues, ensuring comprehensive data capture and audit review processes, and maintaining compliance with federal, state, and local regulations. ➥Oversees high-performing cross-functional teams, including professionals in quality assurance, compliance, privacy, as well as project managers, consultants, investigators, and team leads. ➥Offers valuable insights and guidance on a wide array of quality assurance and compliance matters, encompassing regulatory requirements, change control management, investigations, post-market surveillance, risk analysis, supplier quality management, data integrity, reporting, process validation, project management, quality agreements, and more. -
Senior Quality Assurance ConsultantIndependent Consultant Sep 2010 - Present
Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor Education Details
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Quality Assurance -
Technical Writing -
Medical Writing And Editing Certificate -
Six Sigma Green Belt, Lean Six Sigma, Six Sigma Black Belt
Frequently Asked Questions about Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor
What company does Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor work for?
Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor works for Fda Geek
What is Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor's role at the current company?
Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor's current role is Founder & CEO at FDA Geek - Management Consultant | Quality | Regulatory Compliance | Project Management | Data Integrity | Lean Six Sigma Black Belt.
What schools did Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor attend?
Amit N. Patel, Cqa, Cqia, Csqp, Cqms-Auditor attended California State University-Dominguez Hills, California State University-Dominguez Hills, Nirma University, Ahmedabad, Gujarat, India, Sant Gadge Baba Amravati University, The University Of Chicago, Villanova University.
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