Responsible Pharmacist

Purpose of the JobManage and maintain the Pharmaceutical operation as per the requirements of SAHPRA, SAPC, Value and the clients as well as manage the quality management system (QMS) documentation, records, processes and procedures.Key ResponsibilitiesGeneralMaintain certification to the ISO 13485 standard, as well as the relevant licences required for pharmaceutical and medical-related productsImplement, manage, and maintain all procedures necessary for a successful Quality Management System (QMS), as required by applicable standards and regulationsManage all Corrective and Preventive Actions (CAPAs) resulting from audits to ensure satisfactory resolutionCompile all QMS-related reportsProvide feedback to management on the QMSIdentify corrective actions and improvement opportunities across operationsPromote awareness and understanding of the QMS within the businessOrganise and facilitate QMS meetingsMaintain all QMS documentation and filing systemsPrepare for and schedule Management Review MeetingsUndertake administrative tasks as requiredCarry out general housekeeping within the work environmentEstablish and maintain the organisational structure to ensure adequate staffing by recruiting and placing capable staff in order to meet operational requirementsEnsure succession planning within the operationMonitor staff performanceManage leave, time and attendance of all staffDrive skills development of staff through training and other initiatives as regularly as requiredIdentify problem areas and initiate IR and HR processes as requiredEnsure that all HR and payroll records are in place and maintained (Job profiles, competencies, appraisals, wages etc)Ensure that all staff are well managed, to improve productivity, reduce overtime and ensure that staff are motivated and productivePharmaceuticalsMust be registered as a pharmacist with the South African Pharmacy Council (SAPC)Liaise with the SAPC to ensure statutory compliance and adherence to Good Wholesaling Practice (GWP), Good Pharmacy Practice (GPP), and Good Distribution Practice (GDP) within the Value Logistics warehouseEnsure appropriate licensing of the Value Logistics warehouses, including the timely payment of the annual licence fee to the South African Health Products Regulatory Authority (SAHPRA)Notify SAHPRA of any changes to licensing conditions or the Site Master FileEnsure that a pharmacist continuously supervises the wholesale pharmacy (warehouse operation)Be responsible for the effective, efficient, and safe handling, storage, and distribution of pharmaceutical productsControl access to scheduled products, medical devices, or in vitro diagnostics (IVDs), ensuring that products are delivered only to licensed or registered entities as managed by Value clientsEnsure that contracts are in place between the Value client (contract giver) and Value Logistics (contract acceptor), clearly outlining responsibilities in terms of GWPEnsure contracts with third-party distributors are in placeMaintain Service Level Agreements (SLAs) with all service providers whose services may impact product qualityVerify that all Value clients possess the necessary licences and that pharmaceutical products, medical devices, or IVDs are sourced from legitimate, SAHPRA-registered entitiesEnsure regulatory compliance in procurement, storage, distribution, and proper disposal of medicinal and medical productsMaintain strict documentation and storage controls for Schedule 5 and 6 productsProcure and maintain the most up-to-date reference books as required by the SAPCEnsure that all imported products (on behalf of clients) are sampled per client instructions and that retention samples are kept where applicableAssess compliance of all third-party distributors and transportersReport to management on areas requiring improvementAct as the Pharmacovigilance Responsible Person for Value LogisticsAssume primary responsibility for receiving Adverse Drug Reactions (ADRs) on behalf of clients and ensuring timely forwardingManage and ensure the smooth operation of the pharmaceutical warehouse, ensuring compliance with GWP and GDPOversee all inventory-related functions including receiving, storage, quarantine, picking and packing, cycle counts, and annual stock counts of pharmaceutical and medical productsEnsure compliance with occupational health and safety requirementsDocument and report any out-of-limit conditions to the QA ManagerEnsure that all personnel working in pharmaceutical storage areas possess the appropriate education, training, and experience for their rolesPrevent unauthorised access to restricted pharmaceutical storage areas outside of normal trading hoursEnsure that access to restricted pharmaceutical storage areas is controlled by the pharmacistMaintain accurate records relating to the receipt, possession, storage, safekeeping, and return of pharmaceutical productsRegularly participate in Continuing Professional Development (CPD) programmesEnsure the availability of another pharmacist or locum in the wholesale pharmacy during the Responsible Pharmacist's absenceEnsure that all required reference sources are available in accordance with Regulation 1.2 "Minimum Standards for Pharmacy Premises, Facilities and Equipment" under the Pharmacy ActTrainingPlan, schedule, and conduct training on QMS proceduresManage training records in accordance with company proceduresAuditsPlan and conduct internal quality audits as requiredManage audit close-outs and implement corrective actionsLiaise with auditing and regulatory bodies regarding audit schedules and requirementsManage preparations for, and actively participate in, customer auditsMinimum RequirementsGrade 12 (Matric)Qualified and Registered PharmacistSkills RequiredAdministrative skillsOrganisation skillsComputer literateGood communication skillsTraining skillsInterpersonal skills
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