Ashok Hajare

About Ashok Hajare

Maintaining Compliance with respect to OOS, deviation, market complaint, annual product review, product quality review, stability management and change control.Significant contribution during 483 responses and support provided for lifting the warning latter.Administering escalation of critical incident to Global Quality and health authority communication/Field alert reporting to competent authority. Successfully leading the several product recall’s activities at site and presented during HA’s inspections. e.g. Nitroamine Genotoxic impurity, OOS in Stability studies, Significate GMP incidence and sample handling issue, CRSF product recallControlling overdue compliance activities, human errors, recalls & rejections.Responsible for maintaining Data integrity in GMP documents.Managing Data Lifecycle pathway mapping for various quality system.Conducting self-inspection at site & CAPA follow-up.Involved in the HA Inspections and Inspection Ready Program for sitesDistinctively established & implemented-Transport category for allowable temperature tolerances for transportation which resulted in significant reduction of complaint-Predicted and prevented product recall by implementing Internal release limit using statistical tool which resulted in reduction of stability failure -OOE limit based on release data for all product by using Shyni appPossess excellent interpersonal, analytical trouble shooting & team building skills with proven ability in establishing Quality systems/procedures by utilizing regulatory knowledge to enhance operational effectiveness.

Experience

1. Sr Manager Quality Control

   Sandoz

   Apr 2021 — Present · Mumbai, IN

Education

• Shivaji University

  Master's degree, Chemistry

  2001 — 2003