Quality Assurance Specialist – Laboratory Services

About the role

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

Key responsibilities

• Provide leadership for the implementation and optimisation of laboratory quality management systems.
• Ensure continuous compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
• Interpret and apply SAHPRA regulations, PIC/S guidelines and ISO/IEC 17025 standards.
• Monitor and improve laboratory operational processes to achieve accreditation and regulatory objectives.
• Collaborate with internal stakeholders to embed quality culture and drive technical quality assurance initiatives.

Required profile

• Relevant tertiary qualification in a scientific or engineering discipline.
• Proven experience in laboratory quality assurance or regulatory compliance.
• Strong understanding of South African regulatory frameworks (SAHPRA, SANAS) and international standards.
• Excellent analytical, problem‑solving and communication skills.

Required skills

• cGMP
• GLP
• ISO/IEC 17025
• PIC/S guidelines
• SAHPRA regulations
• SANAS standards
• SABS standards