Quality Compliance Auditor | Abbott EPD | Mumbai

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.