LEAD-AUDITS & ASSURANCE

Job Summary

The GxP External Auditor is responsible for conducting audits to ensure compliance with Good Practice (GxP) regulations across our pharmaceutical clients. This role involves assessing systems, processes, and documentation to ensure adherence to regulatory standards.

Educational Qualification

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• Certification in GxP auditing is preferred.
• Minimum of 5 years of experience in GxP auditing within the pharmaceutical industry.
• Strong understanding of ISO standards and regulatory requirements including CFR Part 11.
• Excellent analytical, communication, and interpersonal skills.
• Attention to detail and strong analytical skills.
• Strong report writing and documentation skills.

Skills

Experience

• Ability to manage multiple audits simultaneously.
• Proficiency in audit management software and tools.
• Experience in Computerized System Validation (CSV).
• Experience in Data Integrity audits.