Purpose Statement<\/p>\n
\tTo 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 \u00a0compliant , efficient and effective laboratory service delivery aligned with SANAS, SAHPRA and SABS requirements.
\n\tTo 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.<\/p>\n
Minimum Requirements\u00a0\u00a0 \u00a0
\nQualifications<\/p>\n
\tAdvanced Diploma or B-degree in quality management, Laboratory Science, Chemistry or Analytical Chemistry, related scientific \/ technical field
\n\tNQF Level 7
\n\tTraining or certification in ISO\/IEC 17025, cGMP\/PICs\/WHO guidelines, Quality Management Systems or Laboratory Quality Assurance will be advantageous<\/p>\n
Experience<\/p>\n
\t8 years\u2019 relevant experience within a GMP laboratory, quality assurance or laboratory quality management environment
\n\tExperience in pharmaceutical laboratory operations, testing processes and quality assurance systems
\n\tSpecialist experience in , GMP, SAHPRA regulations, ISO\/IEC 17025 Quality Management Systems and SANAS accreditation requirements
\n\tExposure to laboratory equipment calibration, verification and maintenance processes, management of out of specification and out of trends and corrective actions<\/p>\n
Duties and Responsibilities\u00a0\u00a0 \u00a0
\nFunctional Management<\/p>\n
\tLead 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.
\n\tDesign, develop and standardise laboratory quality systems, operational processes, procedures and governance frameworks to improve operational effectiveness and accreditation stability.
\n\tReview and monitor laboratory systems, procedures and operational processes to identify gaps, deficiencies and opportunities for continuous improvement.
\n\tEnsure 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.
\n\tSupport laboratory accreditation activities GMP requirements and ensure compliance with applicable PICs, WHO guidelines and accreditation standards and technical requirements.
\n\tReport and communicate the laboratory changes to relevant bodies such as SAHPRA and SANAS.
\n\tMaintenance of SAHPRA license and SANAS accreditation
\n\tKeep abreast with relevant and new regulatory requirements and ensure implementation.
\n\tAssist with the preparation, coordination and follow-up of internal and external audits, assessments and management reviews
\n\tMonitor corrective and preventive actions, non-conformances and quality improvement initiatives to ensure timely closure.
\n\tConduct trend analysis and compile quality, operational and performance reports for management and relevant stakeholders.
\n\tSupport laboratory testing operations by ensuring proper sample handling, traceability and adherence to testing procedures and quality standards.
\n\tCoordinate proficiency testing, method validation, analytical method transfers and verification activities in line with approved procedures and accreditation requirements.
\n\tSupport calibration, maintenance and verification activities for laboratory equipment to ensure operational readiness and compliance.
\n\tAssist in the investigation of quality incidents, deviations, complaints and equipment failures and support root cause analysis and corrective action implementation
\n\tProvide specialist technical and quality guidance to laboratory personnel and management on procedures, quality requirements, accreditation standards and industry best practices
\n\tLead and coordinate laboratory quality improvement initiatives, process optimisation programmes and operational excellence interventions across Laboratory Services.
\n\tAnalyse laboratory operational and accreditation and SAHPRA regulation risks and recommend mitigation strategies to support business continuity and compliance.
\n\tDevelop and present technical, operational and quality management reports, dashboards and recommendations to management and stakeholders.
\n\tAct as a subject matter expert on laboratory quality assurance, cGMP and accreditation systems and laboratory governance requirements.
\n\tManage deviations and Change controls for the laboratory activities.
\n\tDevelop and maintain management of stock levels in the laboratory.
\n\tDevelop and maintain laboratory quality management training material and support staff training and awareness initiatives.
\n\tMonitor compliance with Occupational Health and Safety requirements, laboratory safety procedures and environmental controls.
\n\tEnsure accurate record keeping and maintenance of laboratory data, reports and technical documentation.
\n\tSupport procurement and inventory control processes relating to laboratory consumables and equipment where required
\n\tParticipate in continuous improvement, operational excellence and process optimisation initiatives within Laboratory Services.<\/p>\n
Risk and Compliance Management<\/p>\n
\tAssist in identifying and adhering to fraud controls, risk prevention principles, sound governance and compliance processes, and tools to identify and manage risks
\n\tSupport and provide evidence to all internal and external audit requirements.
\n\tMaintain quality risk management standards in line with regulatory requirements.
\n\tMaintain and enforce all related Service Level Agreements to minimise business risk and ensure business continuity.
\n\tAdhere to all relevant laws, policies and Standard Operating Procedures throughout the Division<\/p>\n
Stakeholder Management<\/p>\n
\tBuild 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.
\n\tRepresent and participate in the organisation’s committees and tasks teams when required.
\n\tConvene and attend meetings and present relevant information stakeholders when required.
\n\tEnsure the provision of excellent customer service.
\n\tResolve queries and problems within span of control and within agreed time frames.
\n\tFollow up on unresolved queries and complaints\/appeals where required.
\n\tLiaise with relevant stakeholders regarding follow-up of and closure of queries.
\n\tProvide subject-matter advocacy and expertise to all relevant stakeholders.<\/p>\n
Deadline:4th June,2026<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( N \/ A ) or<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_company_name":"South African Bureau of Standards (SABS)","_company_website":"http:\/\/N%20\/%20A","_company_tagline":"The South African Bureau of Standards (SABS) is a South African statutory body that was established in terms of the Standards Act, 1945 (Act No. 24 of 1945) and continues to operate in terms of the latest edition of the Standards Act, 2008 (Act No. 29 of 2008) as the national institution for the pro... read moremotion and maintenance of standardisation and quality in connection with commodities and the rendering of services. SABS, offers certification, testing, consignment inspection and other services, mostly to industry. Apart from offering systems certification and product testing against the requirements of South African National Standards (SANS), SABS Commercial also operates its proprietary product certification scheme \u2013 the SABS Mark of Approval, assuring buyers that products are safe, fit for purpose and offer redress","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[12],"class_list":{"0":"post-37021","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"hentry","5":"job_listing_region-gauteng","7":"job-type-full-time"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/37021","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=37021"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=37021"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=37021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}