Sonam Patil

Background

About Sonam Patil

Accomplished and result oriented Professional with extensive industry experience in R&D, clinical, manufacturing, Quality Assurance, Quality Control, Project Management, and Inventory management 2. cGMP, cGCP, cGDP & cGLP trained and well-versed with requirements/best practices in the industry 3. Strong knowledge of ICH, FDA, and Health Canada guidelines and regulations 4. Review MBRs, EBRs, logbooks, and COAs against the specifications, initiate investigations- deviations, OOS, and OOT ensuring compliance with internal SOPs and Industry regulations, propose appropriate CAPAs, to release a safer product in the market 5. Tackling Pharmaceutical manufacturing challenges and enforcing strong quality culture and driving continuous improvement in Quality Management System 6. Extensive Manufacturing knowledge of Tableting, Coating, Hot Melt Extrusion, Hot Melt Granulation, Beads Coating, Encapsulation, and other unit operation techniques used in the pharmaceutical industry 7. Profound Formulation/Process development, Scale-up, Validation, Technology Transfer knowledge 8. Successfully conducted internal & external GMP, GLP, and GCP audits, acting as lead auditor of an audit team. Hosted all client and regulatory audits 9. Strong knowledge of brand and generic products (NDAs, 505(b)2s, ANDAs) 10. Firsthand experience with controlled substances (opioids, CBD, etc.), actively participated in the preparation and attended FDAs Joint meetings of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee Meeting (DSARM) 11. Managing, planning, and coordinating the work and deliverables promptly ensuring that client timelines are met 12. Interacting with internal or external stakeholders to resolve and clarify issues related to projects to facilitate the process 13. Ambitious, hardworking, well-organized, highly motivated, and multitasking professional possessing excellent time management skills with attention to the details 14. Highly developed interpersonal and communication skills and problem-solving skills, with the potential to work independently or within a team setting 15. Ability to work under pressure and obtain consistent results with a strong demonstration of integrity Skills- Project Management, SAP, Gantt Charts, Reporting, MS Word, MS Excel, MS Word, MS PowerPoint, and MS Outlook