Experienced Senior Quality Assurance Executive with a postgraduate degree in Biotechnology and 6+ years of experience in quality assurance, regulatory compliance, and process improvement. Currently thriving at KeyCare Drugs Pvt. Ltd., an In-Vitro Diagnostics (IVD) medical device manufacturer.I am adept at translating complex technical information into clear and concise reports, keeping leadership informed of critical QA initiatives and ensuring alignment with organizational goals.My key strengths include:• Manage compliance with relevant medical device regulations and standards (ISO 13485). Maintain and update the Quality Management System (QMS) to ensure its effectiveness.• Monitor and maintain compliance with relevant quality standards, regulations, and certifications throughout the manufacturing process.• Create QC procedures for materials, production, and testing.• Collaborate with procurement and suppliers to maintain quality standards for raw materials, conducting supplier audits and evaluations as needed.• Provide training and guidance.• Manage quality documents (SOPs, instructions, records).• Investigate quality issues (non-conformances, complaints) & implement CAPAs to prevent them.• Continuously improve manufacturing for efficiency, waste reduction, and quality.• Prepare for audits (internal (ISO 19011) /external) by keeping full docs and ensuring audit readiness. Risk Management (ISO 14971) Report: Identify and mitigate risks to quality and safety in manufacturing.• Collaborate across departments for new products, processes, and regulations.• Oversee the validation and verification of manufacturing processes & equipment. Maintain calibration report.• Promote continuous improvement across quality and manufacturing.As a highly motivated and detail-oriented QA professional, I bring a strong commitment to continuous learning and improvement. I am confident my skills and experience can be a valuable asset to any organization seeking a quality-focused and results-driven professional.