Quality Assurance Manager

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) to comply with USFDA, WHO, NABL, and GLP requirements
• Oversee documentation including SOPs, batch records, test methods, and analytical reports
• Lead and manage USFDA, WHO, NABL, and GLP regulatory audits
• Conduct internal audits to assess laboratory quality system effectiveness
• Lead the CAPA process, including root cause analysis and implementation of corrective actions
• Supervise, mentor, and train laboratory personnel on quality standards and regulatory compliance
• Oversee the review and approval of analytical test results and investigate OOS results
• Implement risk management strategies to mitigate quality-related risks

Requirements

• Minimum of 15 years of experience in a Quality Management role within a pharmaceutical testing laboratory
• Proven experience managing USFDA, WHO, NABL, and GLP audits
• In-depth knowledge of GMP, GLP, FDA, EMA, and ICH guidelines
• Bachelor's or Master's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field
• Strong leadership and team mentoring capabilities
• Proficiency in audit preparation and regulatory reporting

Preferred Qualifications

• Certifications in Quality Management such as Six Sigma or ISO 9001
• Expertise in regulatory affairs

About the Company

EFRAC, part of the QIMA group, is a laboratory testing services company focusing on food safety, pharmaceutical quality control, and environmental monitoring. QIMA operates in over 100 countries, helping brands and manufacturers achieve quality excellence across the consumer products, food, and life sciences industries.