Quality Assurance Specialist

About the role

The Quality Assurance Specialist will lead and govern laboratory quality systems, ensuring compliance with cGMP, SAHPRA, GLP, PIC/S, and ISO/IEC 17025 standards. This role drives operational excellence and technical quality initiatives to deliver efficient, compliant laboratory services aligned with client and regulatory requirements.

Key responsibilities

• Provide leadership for laboratory quality management systems and embed cGMP, GLP, and PIC/S guidelines.
• Maintain ISO/IEC 17025 accreditation and ensure compliance with SAHPRA and SANAS regulations.
• Drive continuous improvement, risk management, and operational excellence initiatives.
• Oversee equipment calibration, verification, maintenance, and manage out‑of‑specification and out‑of‑trend investigations.
• Develop and implement corrective and preventive actions, and support client‑focused service delivery.

Required profile

• Advanced Diploma or B‑degree in Quality Management, Laboratory Science, Chemistry, Analytical Chemistry or a related scientific/technical field.
• Minimum 8 years of experience in a GMP laboratory, quality assurance, or laboratory quality management environment.
• Experience with pharmaceutical laboratory operations, testing processes, and quality assurance systems.
• Training or certification in ISO/IEC 17025, cGMP/PIC/S/WHO guidelines, or Quality Management Systems is advantageous.

Required skills

• cGMP, GLP, PIC/S guidelines
• ISO/IEC 17025 accreditation standards
• SAHPRA and SANAS regulatory frameworks
• Laboratory equipment calibration, verification and maintenance
• Out‑of‑specification (OOS) and out‑of‑trend (OOT) management
• Corrective and preventive action (CAPA) processes
• Risk management and quality management systems (QMS)
• Project management and advanced computer literacy