Amol Dixit

Experience

1. Senior Manager - Quality System Training and Inspection, Regulatory Affairs

   Abbott

   Apr 2016 — Present · Mumbai, IN

   Life cycle management of quality system documents like policies, SOP, process, procedure, and guidelines which ensures a robust, compliant, and efficient Quality System Framework-Collaborate with business process teams and build new or improve existing quality system documents as per changes in regulations, legislations, and business need-Prepare Quality System Metrics/Training Metrics, analyze trends and provide status of compliance to senior management in quarterly Management Review Meetings highlighting compliance issues and ways to rectify it-Manage employee training accounts and assign all quality system documents and other relevant trainings in learning management system (ISOtrain)-Conduct periodic review of the employee training plan and revise it as per job description and other needs-Provide support to audits by planning and tracking requirements per agenda and making quality system documents audit ready. Acting as a back-room coordinator between the SMEs and audit team-Use quality tools and conduct Investigation, Root Cause Analysis and Resolution (CAPA) for all exceptions to quality system documents and record the deviations and non-conformances in SolTRAQs (TrackWise)-Periodic review of the effectiveness of the quality system documents by interaction with SMEs and document users-Use project management skills and operation excellence skills to drive the change management process of quality system documents-Good knowledge about Good Documentation Practices, scientific and medical terminologies-Drive quality culture by conducting events which will build quality and compliance mindset among teams and improve ownership of processes which will reduce delays and re-work.

Education

• University of Mumbai

  Bachelor of Science (B.Sc.), Microbiology, General

  1996 — 1999

• Swami Ramanand Teerth Marathwada University

  Master of Science (M.Sc.), Microbiology

  1999 — 2001