Quality Assurance Manager - Pharma Testing Laboratory

About the Company

QIMA's Food Division focuses on supporting the global food supply chain by ensuring food safety, quality, safe working conditions, and sustainability. We provide inspection, audit, and certification services to food growers, producers, retailers, and food service businesses worldwide. Operating in over 100 countries, QIMA assists more than 30,000 brands across consumer products, food, and life sciences industries to maintain quality excellence. EFRAC, a subsidiary of QIMA, specializes in laboratory testing services related to food safety, pharmaceutical quality control, and environmental monitoring, fostering a culture driven by integrity, client passion, and simplicity.

Job Overview

The Quality Assurance Manager for the pharma testing laboratory will lead the QA function, ensuring compliance with pharmaceutical industry regulations and standards such as USFDA, WHO, NABL, GLP, and internal policies. This role involves managing audits, maintaining a robust quality management system, overseeing CAPA processes, and driving continuous improvement.

Key Responsibilities

• Develop and maintain the Quality Management System (QMS) to meet regulatory (USFDA, WHO, NABL, GLP) and industry standards (ISO, ICH).
• Manage documentation compliance including SOPs, batch records, test methods, and analytical reports.
• Implement risk management strategies to identify and mitigate quality risks within the lab.
• Lead external audits (USFDA, WHO, NABL, GLP) ensuring complete readiness and compliance.
• Conduct internal audits to evaluate the laboratory’s quality system effectiveness and recommend improvements.
• Ensure timely and effective CAPA implementation addressing audit findings per regulatory and company guidelines.
• Serve as the main liaison during external inspections and accreditation processes; collaborate with regulatory bodies for ongoing compliance.
• Lead root cause analysis, non-conformance investigations, and CAPA to ensure prevention of future issues.
• Supervise and train laboratory staff on quality protocols, GMP, GLP, and audit preparedness, fostering a culture of continuous quality enhancement.
• Ensure accurate documentation and timely reporting of analytical results, audit outcomes, and quality metrics.
• Review and approve analytical test results, managing investigation of discrepancies and out-of-specification findings.
• Identify and implement quality process improvements, keeping abreast of industry trends and regulatory changes.

Qualifications and Experience

• Bachelor’s or Master’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related fields; certifications in Quality Management or Regulatory Affairs are advantageous.
• At least 15 years in pharmaceutical quality management, with extensive experience in handling USFDA, WHO, NABL, GLP, CAPA, and internal audits.
• Comprehensive understanding of GMP, GLP, FDA, EMA, and ICH standards.

Skills

• Proven leadership and mentoring capabilities to guide teams towards quality objectives.
• Excellent communication skills for effective coordination with regulatory agencies and management.
• Strong analytical and problem-solving proficiency with risk mitigation expertise.
• Familiarity with laboratory instrumentation and pharmaceutical testing methodologies.
• Expertise in audit preparation, quality documentation, and regulatory reporting.

Additional Information

• Applicants should include total experience, current/expected CTC, notice period, location, and relocation willingness in their application.
• Contact details provided for submission include emails and phone contact.