
SWATI GAIKWAD
About Candidate
A Pharmaceutical and Chemical QA/QC Analyst, a skilled professional ensures product quality and regulatory compliance across multiple industries. With expertise in analytical testing, stability testing, regulatory compliance, and quality assurance. Proficient in preparing stability protocols, operating stability chambers, and managing testing and treatment procedures for gemstones, ensuring that both pharmaceutical, chemical, and gemstone products maintain their integrity throughout their lifecycle.
Education
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Experiences
• Conducted comprehensive research on gemstones (Sapphire, Ruby, Spinel) to enhance clarity, color, transparency, and overall aesthetic quality. • Performed various heat treatments, acid/alkali (hazardous chemicals) cleaning processes, and employed sonicators and tumblers to optimize gemstone characteristics. • Utilized advanced analytical instruments for gemstone evaluation, including Polariscope, Specific Gravity (SG), FTIR, Gemological Microscope, UV-Vis Spectroscopy, Raman Spectrometer. Carried out pre- and post- process analyzes to assess the effects of various treatments on gemstone properties. Reported all experimental results, providing detailed insights and recommendations for improving gemstone quality. Managed gemstone inventory, ensuring accurate tracking of gemstone stocks, treatments, and process status. Developed and prepared Standard Operating Procedures (SOPs) for all instruments and R&D processes, ensuring consistent and safe operation. Prepared fluxes for gemstone treatment processes, facilitating improvement of gemstone clarity and dissolution of inclusions. • Conducted studies on the chemical structure of gemstones, analyzing potential reactions to heat, chemicals, and treatments. • Ensured safety compliance during all research and treatment procedures, adhering to industry standards and best practices.
• Conducted testing of stability samples and finished products in compliance with FDA regulations, cGMP, and ICH guidelines. • Proficient in operating HPLC, IR, LOD, KF, and UV Spectrophotometer for accurate testing and data collection. •Extensive knowledge in the operation and monitoring of stability chambers to ensure the proper storage conditions for stability testing of pharmaceutical products. Data Analysis and Reporting: Analyzed test results using statistical software, providing detailed reports to management and cross-functional teams. Actively participated in investigations of laboratory deviations and OOS results, identifying root causes, implementing corrective actions, and ensuring proper documentation. • Prepared test methods, stability protocols, and reports, ensuring compliance with regulatory standards. • Collaborated with QA, Manufacturing, Regulatory Affairs, and R&D to resolve product quality issues and ensure adherence to quality standards.
Understanding of quality assurance principles and regulatory requirements, ensuring compliance with industry standards. Developed and implemented QA processes, procedures, and systems to improve product quality and efficiency. Managed document control, change control, and deviation management within the Quality Management System (QMS). Analyzed NMR reports and graphs to ensure the chemical structure and purity of products. • Oversaw packaging and dispatch of products, ensuring compliance with regulatory standards. • Managed the purchase of lab equipment and chemicals, ensuring quality and proper inventory.



