Pharmaceutical GMP Lead Auditor

A CQI-IRCA certified pharmaceutical GMP Lead Auditor with more than 18 years of experience in manufacturing and QA functions. Performed more than 150 audits independently for qualifying APIs, intermediates, KSMs, packaging materials, and testing labs

• Quality Assurance Employee

Conducting audits of manufacturing processes, facilities, and systems to ensure adherence to GMP standards.
Evaluating quality management systems against regulatory guidelines such as ICH, 21 CFR, EU GMP, and other applicable guidelines/regulations.
Auditing suppliers and contractors to verify the quality of raw materials and services.
Preparing detailed audit reports and overseeing corrective actions for non-compliance issues.

Strong knowledge of GMP regulations and pharmaceutical quality systems.
Familiarity with industry-specific guidelines like ICH, 21 CFR, and EU GMP guidelines.
Proficiency in auditing techniques and tools, including CAPA procedures.
Excellent communication and analytical skills for reporting and problem-solving.