Job Description

The Role

Purpose:

To lead, manage, and enforce pharmaceutical and operational compliance across the region, ensuring adherence to SAHPRA, ISO, GDP, and GWP standards. The role ensures continuous audit readiness, risk mitigation, and quality control to maintain operational integrity and product safety within the pharmaceutical logistics environment.

Duties:

Lead regional compliance performance by implementing and verifying operational controls to ensure timely closure of nonconformances and continuous audit readiness. Manage operational compliance across branches, directing corrective actions and ensuring adherence to policies, SOPs, and regulatory standards. Ensure sites remain audit-ready in line with SAHPRA and ISO requirements, maintaining document control and evidence packs. Analyse and report regional compliance performance, identifying trends, root causes, and proactive corrective actions. Drive CAPA processes, conduct root cause analysis, and verify closure effectiveness. Facilitate risk assessments, verify change control implementation, and document mitigation measures. Coordinate compliance training, ensuring staff competency aligned to SOPs and regulatory requirements. Manage day-to-day operational compliance issues to maintain business continuity. Maintain and update compliance records, enforcing GDP and documentation standards. Identify, implement, and monitor compliance improvement initiatives, verifying effectiveness. Support branches in adhering to IMS standards and escalate overdue compliance actions. Manage pharmaceutical compliance, ensuring adherence to GDP, GWP, and SAHPRA requirements for temperature control, contamination, and secure handling. Represent RTT in client and regulatory audits, ensuring evidence readiness and closure of findings. Oversee quality control and assurance processes, documentation integrity, deviation management, and training. Oversee validation and qualification of transport vehicles, ensuring compliance with GDP and WHO requirements. Manage systems (TMS, IMS, WMS), ensuring data integrity and traceability across compliance and operational functions.

Skills and Experience

Minimum Requirements:

Matric (Grade 12) - Essential Pharm or B.Pharm Degree -

Essential

2-3 years' experience in pharmacy, warehousing/wholesale, or manufacturing environments Registration with the South African Pharmacy Council (SAPC) -

Mandatory

1-3 years' experience with SHEQ standards, ISO management systems (ISO 9001, 14001, 45001), or SAHPRA compliance Demonstrated experience in audit preparation, compliance data analysis, and CAPA implementation Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) Experience with compliance or reporting systems (e.g., mySHEQ or equivalent) - Advantageous Exposure to audits, compliance reporting, or ISO management systems - Beneficial

Required Knowledge:

SAHPRA, GDP, GWP, and ISO 9001/14001/45001 standards Document control principles, ALCOA+ data integrity standards Risk assessment, CAPA, and change control processes Audit and inspection readiness procedures Pharmacy conduct and regulatory requirements WHO and Medicines and Related Substances Act 101 of 1965 (as amended)

Required Skills:

Strong administrative and organizational capability Excellent verbal and written communication Data collection, analysis, and report compilation Analytical thinking and attention to detail Ability to multitask across multiple branches and compliance priorities Skilled in planning, follow-up, and task completion Proficient in training facilitation and audit coordination

Other

Required Competencies:

Working knowledge of Good Distribution and Good Documentation Practices Understanding of risk and quality management frameworks Ability to interpret and apply SOPs and regulatory requirements High ethical standards, integrity, and accountability Strong problem-solving and decision-making ability Collaborative and results-oriented mindset Continuous improvement and compliance-driven attitude


Job Reference: RTT74134