Purpose Statement
To provide leadership and governance of laboratory quality systems by embedding and optimizing 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 SABS requirements.
To lead, govern and optimise Laboratory Services quality management systems, current Good Manufacturing Practices (cGMP) requirements and SAHPRA regulation, Good Laboratory Practices (GLP), PICs 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.
About SABS
The South African Bureau of Standards (SABS) is mandated to develop, promote and maintain South African National Standards (SANS), promote quality in connection with commodities, products and services, and render conformity assessment services and assist in matters connected therewith. Working for the SABS opens the mind to the world around you. We offer diverse career paths in dynamic environment that nurtures and recognises talent and potential. Become part of our vision of being a trusted standardisation and business assurance solution provider and join a team that fosters accountability, excellence and innovation in an inclusive workplace.
SABS is an equal opportunities employer, and our recruitment will be done in line with the Employment Equity Act 55 of 1998 and our EE Policy. Please note that applications received after the closing date will not be considered.
Qualifications
- Advanced Diploma or B-degree in quality management, Laboratory Science, Chemistry or Analytical Chemistry, related scientific / technical field
- NQF Level 7
- Training or certification in ISO/IEC 17025, cGMP/PICs/WHO guidelines, Quality Management Systems or Laboratory Quality Assurance will be advantageous
Experience
- 8 years’ relevant experience within a 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
Functional Management
- Lead the implementation, governance and continuous improvement of Laboratory Quality Management Systems (QMS) in line with current Good Manufacturing Practices (cGMP) requirements and SAHPRA regulation, Good Laboratory Practices (GLP), PICs guidelines, ISO/IEC 17025, SANAS and SABS requirements.
- Design, develop and standardise laboratory quality systems, operational processes, procedures and governance frameworks to improve operational effectiveness and accreditation stability.
- Review and monitor laboratory systems, procedures and operational processes to identify gaps, deficiencies and opportunities for continuous improvement.
- Ensure the accurate documentation, control and maintenance of laboratory procedures, SOPs, forms, work instructions and quality records, management of out of specification (OOS), and out of trend (OOT) and investigation.
- Support laboratory accreditation activities GMP requirements and ensure compliance with applicable PICs, WHO guidelines and accreditation standards and technical requirements.
- Report and communicate the laboratory changes to relevant bodies such as SAHPRA and SANAS.
- Maintenance of SAHPRA license and SANAS accreditation
- Keep abreast with relevant and new regulatory requirements and ensure implementation.
- Assist with the preparation, coordination and follow-up of internal and external audits, assessments and management reviews
- Monitor corrective and preventive actions, non-conformances and quality improvement initiatives to ensure timely closure.
- Conduct trend analysis and compile quality, operational and performance reports for management and relevant stakeholders.
- Support laboratory testing operations by ensuring proper sample handling, traceability and adherence to testing procedures and quality standards.
- Coordinate proficiency testing, method validation, analytical method transfers and verification activities in line with approved procedures and accreditation requirements.
- Support calibration, maintenance and verification activities for laboratory equipment to ensure operational readiness and compliance.
- Assist in the investigation of quality incidents, deviations, complaints and equipment failures and support root cause analysis and corrective action implementation
- Provide specialist technical and quality guidance to laboratory personnel and management on procedures, quality requirements, accreditation standards and industry best practices
- Lead and coordinate laboratory quality improvement initiatives, process optimisation programmes and operational excellence interventions across Laboratory Services.
- Analyse laboratory operational and accreditation and SAHPRA regulation risks and recommend mitigation strategies to support business continuity and compliance.
- Develop and present technical, operational and quality management reports, dashboards and recommendations to management and stakeholders.
- Act as a subject matter expert on laboratory quality assurance, cGMP and accreditation systems and laboratory governance requirements.
- Manage deviations and Change controls for the laboratory activities.
- Develop and maintain management of stock levels in the laboratory.
- Develop and maintain laboratory quality management training material and support staff training and awareness initiatives.
- Monitor compliance with Occupational Health and Safety requirements, laboratory safety procedures and environmental controls.
- Ensure accurate record keeping and maintenance of laboratory data, reports and technical documentation.
- Support procurement and inventory control processes relating to laboratory consumables and equipment where required
- Participate in continuous improvement, operational excellence and process optimisation initiatives within Laboratory Services.
Risk and Compliance Management
- Assist in identifying and adhering to fraud controls, risk prevention principles, sound governance and compliance processes, and tools to identify and manage risks
- Support and provide evidence to all internal and external audit requirements.
- Maintain quality risk management standards in line with regulatory requirements.
- Maintain and enforce all related Service Level Agreements to minimise business risk and ensure business continuity.
- Adhere to all relevant laws, policies and Standard Operating Procedures throughout the Division
Stakeholder Management
- Build and maintain effective internal and external stakeholder relationships for the purpose of expectations management, knowledge sharing and integration, and to manage the organisation's reputation.
- Represent and participate in the organisation's committees and tasks teams when required.
- Convene and attend meetings and present relevant information stakeholders when required.
- Ensure the provision of excellent customer service.
- Resolve queries and problems within span of control and within agreed time frames.
- Follow up on unresolved queries and complaints/appeals where required.
- Liaise with relevant stakeholders regarding follow-up of and closure of queries.
- Provide subject-matter advocacy and expertise to all relevant stakeholders.
