The Busamed Hospital Group is an award winning, proudly South African private hospital group providing specialist services in 7 state-of-the art hospitals across South Africa.
Key Responsibilities : Maintain the Site Master File and ensure compliancy to regulation guidelines set out by the South African Health Products Regulatory Authority (SAHPRA) and South Africa Pharmaceutical Council (SAPC)Delivering high standards of pharmaceutical care for the end-to-end management of dispensary operations in accordance with Good Pharmacy Practice and Good Wholesale PracticeMaintain pharmacy plans, Standard Operating Procedures (SOPs) and other relevant documentation required by law.
Overall control within the guidelines for warehouse as per Pharmacy Council specificationsParticipate in and contribute to the development and achievement of the corporate goals and objectivesRegistrations and Licenses SAHPRA, SAPC and Dept of Health : Annual Fees, Inspections and Responses and Communications.
Overall compliance with the Laws and Regulations.Identify regulatory and quality training needs, and delivering trainingLeads liaison with regulatory bodiesKey Duties : To dispense study related drugs according to project specific protocols and SOPsOversee coordination of logistics activities by ensuring clinical supplies are receipted, stored and distributed in accordance with Busamed Hospital Services approved procedures and policies, cGMP, cGDP, and regulatory requirements.
Manage and control returns, quarantine, destruction, expired stock and batch recallsTo liase with the QA Manager for the implementation of changes to pharmacy plans, SOPs and other relevant documentationTo monitor drug storage conditions and record keepingTo monitor 100% drug accountability and compliance with randomisation codes as per study specific proceduresEnsure that required environmental conditions are continually metPerfom departamental self inspectionsParticipate and follow up on actions from monthly quality control monitoringParticipate in study-related trainingAssist in the investigation of internal and external non conformances through to resolution where requiredAssist in the investigation of customer complaints through to resolution where requiredLiaise closely with clients on return drugs & destruction.
Assist in internal audits according to SOP requirement and assist in regulatory, supplier and client audits.Lead / Participate in recalls when neededAssist in the QA / GMP training of employees across the companyProvide leadership, training and career development for all subordinatesDesign KPI reports to monitor daily and monthly performance.
Contribute in weekly and monthly management meetings.Design a structure that can provide high standards of service.Other : Perform any reasonable task, in line with the businesss goals, as requested by upward liaison on projects and improvement initiatives as required by ManagementParticipate in ad hoc assignmentsPerform other duties that are commensurate with the jobManage and plan daily duties and tasksKey Performance Metrics in line with PMD : Provide operational excellence in areas of responsibilityEnsure a 100% achievement in area of responsibility for all internal / external QA auditsEducationGrade 12 / Metric.
BPharm) degreeWorking Experience : Minimum of 5 years practical experience working within a Pharmaceutical environment.Knowledge of SAHPRA & SAPC regulations / guidelinesIn depth knowledge of legislation pertaining to the pharmaceutical industry and understanding of functions and responsibilities of a Responsible Pharmacist as per the medicines act, pharmacy act and cGMP Guidelines.
Software Skills : Proficient to Advanced Microsoft office skills.
Excel, Word, Power Point.
GPM .Other skillsAbility to work under pressure and to support others within the team.Excellent written and verbal communication, computer, analytical problem solving, planning / organizational, interpersonal / teamwork, negotiation and leadership skills are necessary.
Extensive spreadsheet analysis and strong mathematical abilitiesAbility to co-ordinate various processes simultaneouslyDetail oriented with extreme accuracyAbility to work cross-functionally.
Attributes : PlanningProblem solvingFollow upTime managementGood communication skillsInitiativeCustomer serviceTelephone etiquetteFinancial orientation