Sugandhini K.

About Sugandhini K.

Material Development Specialist with 7 years of industry experience, well-versed in FDA, USP, and ISO regulations. Proficient in tools across project phases, including requirement analysis, design, testing, and support. • Quick learner with a strong ability to adapt to SAP tools. Skilled in interpreting regulatory documents (SDS, ISO, Vegan, RSPO, GMP, Annex 14, REACH, CoA). • Established solid relationships with pharmaceutical industry suppliers and manufacturers, ensuring efficient information exchange, problem resolution, and commitment to high production standards. • Familiar with drug development and approval processes, including clinical trials, regulatory pathways, and requirements for different drug types. • Expertise in creating Raw Material Specifications in SAP RD for transparent labeling using EPIC. • Proficient in working with APIs and Analytical Instrumentation, developing tailored methods for effective development. • Created SOPs and Batch Records for Transdermal Patches meeting GLP and GMP standards. • Conducted Flux and Stability Studies to evaluate the effectiveness of formulations in delivering chemotherapeutics through the dermal layer. • Skilled in using incident management software such as ServiceNow, Jira, and Citrix.

Experience

1. Materials Development Specialist

   Coty

   Oct 2022 — Present · Morristown, NJ, US

   Created raw material specifications using SAP RD to ensure compliance with global FDA standards.Developed and maintained comprehensive documentation for raw material specifications, contributing to efficient quality control processes.Collaborated with cross-functional teams to integrate SAP RD into the overall regulatory workflow, improving data accuracy and streamlining processes. Conducted regular audits to verify the accuracy and completeness of raw material specifications per regulatory requirements.Provided training to team members on SAP RD functionalities.Collaborated with suppliers and vendors from various locations to source high- quality raw materials for Analytical Testing and established strong partnerships to ensure a stable supply chain.