GMP Lead Auditor– International Life Sciences
Core
Conduct on-site and remote audits of API manufacturers, excipient suppliers, and pharmaceutical/healthcare facilities to ensure compliance with GMP, GDP, GLP, and GCP standards.
Role type
Senior GMP Auditor (Quality Assurance)
Builds
Compliance assurance and risk mitigation for pharmaceutical and healthcare supply chains
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP auditing, GxP regulations knowledge, regulatory gap analysis, corrective and preventive action planning, audit reporting, international travel
Preferred skills
GLP and GCP knowledge, additional languages beyond English
Technologies
GxP regulatory frameworks
Responsibilities
Conduct on-site and remote audits of API manufacturers, excipient suppliers, and pharmaceutical/healthcare facilities; Evaluate compliance with GxP regulations and identify gaps, risks, and improvement opportunities; Review documentation, procedures, and quality systems, proposing corrective and preventive actions; Prepare clear, accurate, and professional audit reports; Stay up to date with regulatory requirements and industry best practices.
Seniority
Mid-Senior, hands-on IC