Sejal Patel
About Sejal Patel
• Self-motivated quality and regulatory management professional with extensive experience in the Biologics, Pharmaceutical and Medical device industries. • Expertise in current Good Manufacturing Practices. Hands on experience in Gene and Cell Therapy, Viral vector manufacturing, Plasmid production, quality engineering and regulatory compliance. • Proficient at writing quality system, process control, and inspection/test documents. • Proven hands on experience with CAPA, Management Review, Process Control, process validation, training and design assurance support. • Experience in risk analysis and non-conformance investigation and dispositioning. • Proficient in managing Internal/External audits and vendor qualification program. • Expertise in performing annual product reviews, product complaints, quality investigations, root cause analysis, change control, batch record review and CAPA effectiveness. • Specialized in SAP, JDE, Track wise, CRTS, SharePoint, LIMS, QCBD, Veeva and LMS/Plateau. • Provide technical, regulatory, safety, GCP and GMP Training to functional areas. • Well-developed communication, project management and leadership skills including delegating and coordinating tasks, planning and implementing change, and motivating cross-departmental teams.