Shivangi Panchal

- Execution of method development, validation and stability studies as per regulatory requirement - Execute QA processes along with change controls, CAPA and deviations - Maintenance, Calibration and qualification of modern analytical instruments - Provide assistance in internal and query-based customer audits - Ensuring QC goals and method implementation in coordination with cross-functional teams

• Method development and validation on instruments such as HPLC & GC • Stability studies of API & in-process material • Standard qualification and calibration of instruments • Wet analysis of LOD, Water content and ROI using instruments like Karl Fischer, pH meter • Prepare validation protocols and reports • Presentation related to method development activity

• Method validation on HPLC, GC, Dissolution • Standard qualification and maintenance of products • Prepare validation protocols and reports, assistance in internal audits, query-based customer audits • Force degradation studies

• Review, compilation and documentation of Product Development Reports, SCR, Process, R&D journals, product flow chart, RMC data and SOP • Review of specifications, standard test procedures, validation protocols, reports of raw materials, in-process, intermediates and API • Preparation of Certificate of Analysis as per BP, USP, IP, EP and Vendor Specification. • EC filing documents and CPHI documents

• Initiator of Change controls related to ADL & QC on Trackwise software • Review, compilation and documentation of Product Development Reports, SCR, Instrument Qualification data • Prepare monograph evaluation reports, standard test procedure, validation protocol and report of raw material, in-process, intermediate and API

Specialization in Pharmaceutical Chemistry Academic projects and Research works: • Design and Synthesis of Novel Porcupine Inhibitors as anticancer agents • Recent advances in Sodium Glucose Co-transporter Inhibitors against Diabetes