Chandresh Patel

Background

About Chandresh Patel

More than twenty five years of combined experience in pharmaceutical, oncology and biotechnology operations. Network leadership role. Responsible for rollout of global Readily Apparent Assignable Cause (RAAC) LIR workflow in gQTS (TrackWise). Excellent communication and problem solving skills. • QA and QC Responsibilities: Global Change Management, Quality Metrics Reporting, Managing Lab operations, Investigations, Effective CAPA implementation, Audits, Technical Reports, SOPs and LAB documents. Review compendia changes and corporate policies and/or quality standards affecting site documents. Inspection Readiness. • Collaborate with applicable team members or other department/division in a cross-functional meeting to resolve scientific and technical investigation related issues and implement effective CAPA and thereby reducing number of investigations. • Provide quality support during numerous BOHs inspections, corporate audits: Inclusive of Pre-approval inspection for ANDA pharmaceuticals, oncology (NDA) and vaccine products (NDA), General GMP Audits/Inspection and post-marketing commitments.