Yogesh Sonwane

Experience

1. Deputy Project Manager

   Fidelity Health Services

   Jan 2020 — Present · Mumbai, IN

   Team lead of case processing team of size 20 associates.• Workflow manager for influx and daily production• Compliance management: Regulatory, submission compliance and Training compliance.• Managing workflow according to timelines and SLA. Tracking of all service level agreement and ensure the achievements.• RCA CAPA management: End to end handling, assigning RCA CAPA, following up with team for closure of CAPA in timeline, maintaining tracker for deviations, evaluating implementation of CAPA with documentation.• Induction to sign off assistance to new joiners.• Leave planner.• Periodic submission to USFDA• Managing USFDA, PvPI CDSCO, TGA, Russia, Canada submission independently.• Faced FDA MHRA Canada and client audits• To deliver relevant training to the team as per the requirement of the project• To coordinate the workload and manage staff as per the workload on a project• To be a one-point contact for the client and managers• Ensure effective training and certification of the team for processing PV cases• To be aware and make team members aware of client standards and SOPs