KGAUGELO MAGGY MASIPA

• Manage the day-to-day distribution of Schedule 6 medicines in compliance with the Medicines and
Related Substances Act and Good Distribution Practice (GDP)
• Perform and oversee the receipt, storage, picking, verification, and dispatch of Schedule 6 medicines.
• Maintain and reconcile Schedule 6 registers, ensuring accurate record keeping and legal compliance.
• Investigate Schedule 6 stock discrepancies.
• Verify and authorize Schedule 6 orders prior to dispatch, ensuring legal and quality requirements are met.
• Monitor secure storage and controlled access to Schedule 6 medicines.
• Conduct routine cycle counts and stock audits of Schedule 6 inventory.
• Investigate and document Schedule 6 incidents, discrepancies, and non-conformances, implementing corrective actions where required.
• Ensure full traceability of Schedule 6 medicines through receipt, storage, and distribution.
• Review and maintain Schedule 6 documentation, including registers, reconciliation records, and audit trails.
• Support internal and external audits relating to controlled medicines and ensure inspection readiness.

• Compliance to: Act 101 of 1965; Pharmacy Act 53 of 1973 SAHPRA std and
  GWP/PICS/WHO guidelines, OSH act.
• Assisting the Responsible Pharmacist (RP) with all tasks where required.
• Deputize the Responsible Pharmacist (RP) by performing all RP duties and accepting responsibility as stand in RP in the absence of the RP.
• Quality systems/SOPs drafting, training and maintaining
• Product Releases as per Client's specifications
• Audits (preparation and correcting any non-conformances found) and CAPA initiation and close-out.
• Raise, maintain and monitor deviations, change controls and CAPA’s as well as trackers.
• Dedicated storage area management (Damages, Quarantine, Returns, Cold-Chain Store & Schedule Stores)
• Management of samples and sampling processes
• To implement and train on Quality systems, SOPs and GDP
• Supervision of importing, releasing, storage, packaging, supplying and/or selling of any medicine or schedule substance

Unit and core function: Medical Devices and IVDs

• Comprehensive knowledge and understanding of relevant legislation, Medicine and Related Substances Act 101 of 1965 and Regulations
• Ethical behavior and adherence to the SAHPRA Code of Conduct
• Administration and Techinical evaluation of license applications of Manufacturing, Distribution and Wholesaling establishments of medical devices and IVDs
• Working knowledge of ISO 9001: 2015 and ISO 13485: 2016 standards
• Drafting and issuing of applicable licenses
• Performing risk-based evaluation of vigilance reports for medical devices and IVDs
• Following up on any reported adverse events
• Maintaining relevant databases
• Chairing and facilitating meetings within the unit
• Developing and maintaining guidelines and SOPs for Medical Devices Licensing and Vigilance
• Recording and reporting of applicable statistics
• Manage correspondence from stakeholders and applicants
• Liaising with Regulatory Compliance unit for any field safety notices, recalls and any product quality complaints investigations
• Executing all delegated tasks

• Compliance and adherence to GDP, GWP and working knowledge of cGMP
• Compliance with Medicine and Related Substance Act and Pharmacy Act (regulatory bodies and authorities)
• Executing daily Quality Assurance activities
• Responsible for batch releases and Sampling
• New product listing
• Managing and reporting of CAPA and deviations
• Management of product returns, recalls and destructions

• Pharmacy Manager and Responsible Pharmacist
• Pharmacy management and administration
• Responsible for regulatory compliance of the pharmacy by ensuring adherence to pharmaceutical laws and regulations enforced by SAHPRA, SAPC and Department of Health
• Operational work planning and goal setting and prioritization tasks to achieve defined indicators
• Task delegation to achieve various pharmacy goals
• Managing cross functional relationships with prescribers, suppliers and higher management
• Dispensing medicines, OTC and Prescriptions to private clients
• Dispensing and handling of scheduled drugs
• Educating and tutoring staff to ensure continuous education and development
• Supervision of Pharmacy staff and solving operational and staff problems
• Stock Control including ordering, performing stock rotation, cycle counts and stock take
• Managing budgets in liaison with regional management
• Keeping statistical and financial records, as well as other business reports

A community service pharmacist in a public tertiary hospital responsible for :

• Identification of medicine supply challenges and make follow up with suppliers for stock delivery queries
• Implementation of the Essential Drug Programs (EDP) as per in the National Department of Health strategies
• Evaluation and monitoring of rational drug use at primary health facilities dependent to the hospital
• Dispensing of valid prescriptions to in-patients, out-patients and oncology prescriptions
• Handling of Schedule substance and ward inventory management
• Compounding of solids, semi solids and liquid dosage forms in the hospital small scale compounding area
• Preparation and compounding of chemotherapeutic drugs and ensuring sufficient availability of treatment for daily administration