Specialist Quality Assurance

About the position

Purpose:

To provide leadership and governance of laboratory quality systems by embedding and optimising cGMP requirements,SAHPRA regulations,GLP and PIC/S guidelines and ISO/IEC 17025 accreditation standards. Drive operational excellence and technical quality assurance initiatives that ensure compliant, efficient and effective laboratory service delivery aligned with SANAS,SAHPRA and company [URL Removed] lead govern and optimise Laboratory Services quality management systems,current Good Manufacturing Practice (cGMP) requirements and SAHPRA regulation,Good Laboratory Practices (GLP),PIC's guidelines, accreditation compliance, laboratory operational excellence and technical quality assurance initiatives to ensure effective, compliant and efficient laboratory service delivery in line with SANAS,ISO/IEC 17025,SAHPRA regulations and SABS requirements.
Role requirements:

• Advanced Diploma or B Degree in quality management ,Laboratory Science, Chemistry or Analytical Chemistry or related scientific/technical field.
• Training or Certification in ISO/IEC 17025,cGMP/PICs/WHO guidelines, Quality Management Systems or Laboratory Quality Assurance will be advantagious.
• 8 years relevant experience with GMP laboratory, quality assurance or laboratory quality management environment.
• Experience in pharmaceutical laboratory operations, testing processes and quality assurance systems.
•  Specialist experience in GMP,SAHPRA regulations,ISO/IEC 17025 Quality Management Systems and SANAS accreditation requirements.
• Exposure to laboratory equipment calibration, verification and maintenance processes, management of out of specification and out of  trends and corrective actions.

Desired Skills:

• quality management systems
• project management
• risk management practices