Komalpreet Kaur

Results-oriented Quality Assurance professional with over 6 years of experience in Pharma/Healthcare & Medical Devices. Proven expertise in managing Quality Management Systems, including Deviation, Change Control, Market Complaints, Investigation, CAPA, Risk Assessment, Observations, Artworks, Quality Review, and Regulatory Inspections. Skilled at developing innovative approaches to resolve complex problems and promoting high product quality standards. Adept at developing research programs to improve existing products and explore the potential of new products. Proactive in coordinating daily activities of QA staff and ensuring legal compliance and regulatory standards are met. Proficient in administering and enforcing QA standards, conducting audits, processing information, and taking appropriate action. Motivated and goal-driven team leader with strong work ethics, continuously striving for improvement and demonstrating excellent administrative aptitude. Committed to deliver quality work and achieving organizational objectives.

CE Marking

• Victoriously designed & implemented Compliance Artwork Excellence Report
• Best presenter during Management Review
• Introduced Procedure at site for Management of Artworks
• Successfully delivered global project implementation at site

• Audits Exposure: USFDA, MHRA, TGA- Australia, WHO-GMP, CDSCO, Russia, Health Canada & ISO 13485 & 9001
• Gained experience in Investigative Analysis (All tools), Risk Assessment, Change Controls
• Proficient in providing guidance and continuous support, decision making and problem solving as SME to warehouse for GMP compliance regulatory QC standards.
• Possess a keen observer quality showcased in GEMBA Walk
• Excellent at partnering / collaborating with stakeholders to achieve organization’s strategic objectives
• Exposure of dosage forms - Tablets, Creams/Ointments, Liquid Syrups, Suspensions & Medical Devices