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 and relevant licenses for pharmaceutical and medical products.
- Implement, manage, and maintain procedures for a successful QMS, complying with standards and regulations.
- Manage Corrective and Preventive Actions (CAPAs) from audits to ensure resolution.
- Compile QMS-related reports and provide feedback to management.
- Identify corrective actions and opportunities for improvement.
- Promote awareness of the QMS within the organization.
- Organize and facilitate QMS meetings and maintain documentation and filing systems.
- Prepare for Management Review Meetings and undertake administrative tasks.
- Maintain a safe and organized work environment.
- Establish organizational structure to ensure adequate staffing, including recruitment and succession planning.
- Monitor staff performance, manage leave, and drive skills development.
- Manage HR and payroll records and ensure staff productivity and motivation.
Pharmaceuticals
- Must be a registered pharmacist with SAPC.
- Ensure compliance with GWP, GPP, GDP, and statutory licensing requirements.
- Maintain licenses, notify SAHPRA of changes, and supervise warehouse operations.
- Handle pharmaceutical products safely, control access, and ensure contracts and SLAs are in place.
- Verify client licenses and source legitimacy, ensure regulatory compliance, and manage documentation.
- Oversee inventory, manage adverse drug reactions, and ensure personnel are qualified.
- Participate in CPD and ensure pharmacist availability during absences.
Training
- Plan and conduct training on QMS procedures and manage training records.
Audits
- Plan and conduct internal audits, manage audit outcomes, and liaise with regulators and clients.
Minimum Requirements
- Grade 12 (Matric)
- Qualified and Registered Pharmacist
Skills Required
- Administrative, organizational, and computer skills
- Good communication, training, and interpersonal skills