Palak P.

• Master's Degree in Pharmacy with major in Pharmaceutics. • Knowledge of the Quality assurance/ Regulatory/Quality Control/Production and basic clinical research . • 6 to 7 years of experience in a Quality Assurance/Quality control • GMP/GDP Quality Assurance/Auditing 3 to 4 years of experience. • CAPA, Risk assessment experience 3 to 4 years. • Experience in Quality Management System for Medical Devices/Pharmaceutical, maintained and in compliance with local and international standards and regulations (i.e. ICH,ISO 13485, US-FDA, EU Medical Device Directive, CDSCO) for medical device and pharmaceutical. • Proficiency with Microsoft Word, Excel, Outlook, PowerPoint, Adobe Acrobat • Good written and excellent verbal communication skills. • Excellent organizational skills and the ability to multitask. • Proficient in the follow instruments: visual Inspection, pH-Conductivity, Titrations, UV/Vis, Micrometer, Caliper, Plug/Pin/Thread Gages, Feeler Gages, Microscope, Moisture Analyzer, Viscometer, Lyophilizer, Dossimeter, HPLC, GC and FTIR • Knowledge and experience in QC Testing : Stability, Bioburden, Environmental monitoring, Titration Etc. • Detail oriented, accurate and able to solve problems • Experience in Dossier preparation of different country guideline