Hi, Greetings! I am Raghukul Chaudhary, a postgraduate in Biotechnology with over 4 years of professional experience in Quality Assurance (QA) and Regulatory Affairs, specializing in In-vitro Diagnostics (IVD), Rapid Diagnostic Tests (RDTs), and Medical Devices.
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​With over 4+ years of hands on experience in In-vitro Diagnostics (IVD) and Medical Devices. I have worked in both QC, QA and RA departments during my professional career. I have gained hands-on experience in Quality Management Systems (QMS), with a strong focus on ensuring compliance with regulatory standards, preparing technical documentation, and contributing to the successful licensing of medical devices in India.
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I am skilled in various aspects of Quality Assurance, including Training Management, Conducting Internal Audits, Perform Root Cause Analysis (RCA) using 7QC Tools, Deviation Management, Post Marketing Surveillance (PMS), and Complaint Handling. My expertise extends to managing critical documentation processes such as MFR (Master Formula Record), IHS (Instruction for Use), STP (Standard Testing Procedures), CAPA (Corrective and Preventive Actions), Non-Conformance Reports, SOPs (Standard Operating Procedures), Device Master File (DMF), Site Master File, and licensing requirements. I am also well-versed in adhering to strict safety protocols, GMP (Good Manufacturing Practices), and conducting risk assessments.
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​In addition to my technical skills, I am a highly motivated and fast learner who thrives in dynamic environments. I am passionate about continuous improvement and have a proven track record of establishing best practices and adapting them to meet evolving challenges. My colleagues often describe me as persistent, honest, and reliable—qualities that have helped me build strong professional relationships and deliver consistent results.
​When it comes to learning, I believe in leveraging multiple resources—books, blogs, online courses (like Udemy and Edx), and insights from experienced professionals. I avoid reinventing the wheel and instead focus on refining existing processes to achieve excellence. My goal is to contribute to innovative projects in the healthcare and medical devices industry while continuing to grow both personally and professionally.
​What do others say about me? They say I'm persistent, honest and reliable.
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​Let’s connect and explore how I can bring value to your team!