Quality Compliance Auditor | Abbott EPD | Mumbai

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Job Overview

  • Date Posted
  • Location (State / UT)
  • Expiration date
  • Experience
    10 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree
  • Salary in (₹)

Job Description

Responsibility :

  • Manage on-site/desktop audits and evaluate Regional suppliers and Third Party Manufacturers
  • Create, maintain and execute Audit Schedules in the Trackwise Audit system and ensure its compliance
  • Review Quality Questionnaires returned by the Suppliers/TPMs and resolve any issues.
  • Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for supplier and TPMs audits
  • Participate in internal audits of Manufacturing site & affiliates auditing program.
  • Review & verify CAPA for observations arising from Regulatory Agency audits & Internal audit observations, at the manufacturing site for its completeness and implementation.
  • Manage Affiliate Audit program,
  • Support the regional management in the execution of various assigned tasks

Experience & Skills:

  • Performing Audits in Drug products – Sterile & Non-sterile, API, Biosimilar products, etc.
  • Excellent communication skills & report writing skills in the English language
  • Risk analysis, CAPA Development
  • Computer skills for Microsoft Presentation / Word Document /Excel & PDF
  • 10+ years of experience in Pharma Auditing in an MNC / Large Pharmaceutical Company.