Purpose of the Job

Manage 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 Responsibilities 

General

• Maintain certification to the ISO 13485 standard, as well as the relevant licences required for pharmaceutical and medical-related products
• Implement, manage, and maintain all procedures necessary for a successful Quality Management System (QMS), as required by applicable standards and regulations
• Manage all Corrective and Preventive Actions (CAPAs) resulting from audits to ensure satisfactory resolution
• Compile all QMS-related reports
• Provide feedback to management on the QMS
• Identify corrective actions and improvement opportunities across operations
• Promote awareness and understanding of the QMS within the business
• Organise and facilitate QMS meetings
• Maintain all QMS documentation and filing systems
• Prepare for and schedule Management Review Meetings
• Undertake administrative tasks as required
• Carry out general housekeeping within the work environment
• Establish and maintain the organisational structure to ensure adequate staffing by recruiting and placing capable staff in order to meet operational requirements
• Ensure succession planning within the operation
• Monitor staff performance
• Manage leave, time and attendance of all staff
• Drive skills development of staff through training and other initiatives as regularly as required
• Identify problem areas and initiate IR and HR processes as required
• Ensure 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 productive

Pharmaceuticals

• Must 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 warehouse
• Ensure 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 File
• Ensure that a pharmacist continuously supervises the wholesale pharmacy (warehouse operation)
• Be responsible for the effective, efficient, and safe handling, storage, and distribution of pharmaceutical products
• Control 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 clients
• Ensure that contracts are in place between the Value client (contract giver) and Value Logistics (contract acceptor), clearly outlining responsibilities in terms of GWP
• Ensure contracts with third-party distributors are in place
• Maintain Service Level Agreements (SLAs) with all service providers whose services may impact product quality
• Verify that all Value clients possess the necessary licences and that pharmaceutical products, medical devices, or IVDs are sourced from legitimate, SAHPRA-registered entities
• Ensure regulatory compliance in procurement, storage, distribution, and proper disposal of medicinal and medical products
• Maintain strict documentation and storage controls for Schedule 5 and 6 products
• Procure and maintain the most up-to-date reference books as required by the SAPC
• Ensure that all imported products (on behalf of clients) are sampled per client instructions and that retention samples are kept where applicable
• Assess compliance of all third-party distributors and transporters
• Report to management on areas requiring improvement
• Act as the Pharmacovigilance Responsible Person for Value Logistics
• Assume primary responsibility for receiving Adverse Drug Reactions (ADRs) on behalf of clients and ensuring timely forwarding
• Manage and ensure the smooth operation of the pharmaceutical warehouse, ensuring compliance with GWP and GDP
• Oversee all inventory-related functions including receiving, storage, quarantine, picking and packing, cycle counts, and annual stock counts of pharmaceutical and medical products
• Ensure compliance with occupational health and safety requirements
• Document and report any out-of-limit conditions to the QA Manager
• Ensure that all personnel working in pharmaceutical storage areas possess the appropriate education, training, and experience for their roles
• Prevent unauthorised access to restricted pharmaceutical storage areas outside of normal trading hours
• Ensure that access to restricted pharmaceutical storage areas is controlled by the pharmacist
• Maintain accurate records relating to the receipt, possession, storage, safekeeping, and return of pharmaceutical products
• Regularly participate in Continuing Professional Development (CPD) programmes
• Ensure the availability of another pharmacist or locum in the wholesale pharmacy during the Responsible Pharmacist’s absence
• Ensure that all required reference sources are available in accordance with Regulation 1.2 “Minimum Standards for Pharmacy Premises, Facilities and Equipment” under the Pharmacy Act

Training

• Plan, schedule, and conduct training on QMS procedures
• Manage training records in accordance with company procedures

Audits

• Plan and conduct internal quality audits as required
• Manage audit close-outs and implement corrective actions
• Liaise with auditing and regulatory bodies regarding audit schedules and requirements
• Manage preparations for, and actively participate in, customer audits

Minimum Requirements

• Grade 12 (Matric)
• Qualified and Registered Pharmacist

Skills Required

• Administrative skills
• Organisation skills
• Computer literate
• Good communication skills
• Training skills
• Interpersonal skills