Yamini Haridas

A seasoned Quality Control Lead with 13 years of experience in R&D, specializing in QC, product validation, data analysis, and troubleshooting. Seeking to leverage expertise in quality assurance and leadership to drive excellence in product quality and regulatory compliance.

Meticulous and knowledgeable professional with over 13 years of experience in R&D and QC. Certified Internal Auditor for ISO 9001:2015 and ISO 13485:2016. Proficient in developing and maintaining records, handling customer queries, and facilitating cross-departmental collaboration. Skilled in conducting various tests and inspections for various processes. Strong communication skills acquired through national and international conference presentations and official correspondence for scientific projects. Well-versed in QMS activities, dossier preparations for FDA and WHO, and risk assessment for new products/processes. Experienced in building quality systems, implementing procedures, and managing quality-related activities.

• ISO 13485 Awareness Program, TUV SUD South Asia, 2013
• Internal Auditing for Quality Management System based on ISO 13485:2016
• ISO 14971:2019 Awareness Training on Risk Management
• WHO Prequalification Virtual Workshop for IVD Manufacturers
• Certified Internal Auditor for ISO 9001:2015 and ISO 13485:2016

• Troubleshooting quality issues during R&D stages for new products.
• Handling queries from the marketing team regarding product applications at customer's end.
• Successfully developing and transferring technology for various rapid tests and immuno-turbidimetry reagents.
• Conducting risk management assessments for products as per ISO 14971.
• Providing post-sales troubleshooting assistance and pre-sales networking.
• Training newcomers and grooming them in understanding the product portfolio.
• Handled queries from marketing team regarding product application at customer’s end.
• Spearheaded the establishment of comprehensive quality control processes for a rapid test manufacturing company, ensuring adherence to industry standards and regulatory requirements.
• Developed and implemented protocols for product validation, data analysis, and troubleshooting, resulting in improved product quality and reliability.
• Designed and executed training programs for QC staff to ensure proficiency in quality control procedures and compliance with established protocols.
• Collaborated with cross-functional teams to streamline quality procedures and identify areas for continuous improvement, resulting in enhanced efficiency and productivity.
• Successfully led the company through ISO certification audits, WHO prequalification assessments, and FDA inspections, demonstrating adherence to stringent quality standards.
• Received accolades from management for achieving significant improvements in product quality, customer satisfaction, and regulatory compliance.
• Orchestrated WHO Projects: Successfully led multiple projects aligned with World Health Organization (WHO) standards, ensuring compliance with stringent regulatory requirements and international quality standards.
• Effectively managed WHO inspections for our projects, demonstrating meticulous attention to detail and adherence to WHO guidelines. The successful outcome of these inspections underscored our commitment to quality and regulatory excellence.
• Fostered strong collaboration between various departments and stakeholders to streamline processes, enhance communication, and ensure seamless coordination throughout WHO projects.

• Madhya Pradesh Council of Science and Technology (MPCST), Fellowship, 2008, 2011
• Indian Science Congress Association (ISCA), Lifetime member

• Title: Quality Control Lead
• Date of Birth: 08/20/83
• Marital Status: Married

• Regional Seminar on Intellectual & Innovation Management, NRDC, 2009
• Hands-on Molecular Biology Techniques, Boston College, 2008
• Training at High Security Animal Disease Laboratory, IVRI, 2007
• Training at Defense Research and Development Establishment (DRDE), 2003