Specialist : STQC

Purpose :

The Specialist : STQC is responsible for managing and enforcing compliance, quality, and operational integrity across their designated region. This role ensures full implementation of ISO, SHEQ, and pharmaceutical regulatory requirements, maintaining audit readiness, risk control, and operational excellence. The STQC leads branch alignment, drives corrective actions, and partners with operations to sustain compliance performance, customer confidence, and continuous improvement across all business functions.

Duties : Responsibilities

• Lead regional compliance performance by implementing and verifying operational controls, ensuring timely closure of nonconformances, and maintaining continuous audit readiness.
• Manage operational compliance requirements across branches, direct corrective actions, and provide guidance to ensure full adherence to policies, SOPs, and regulatory standards
• Ensure all sites remain audit-ready by managing document control, reviewing records, and coordinating evidence packs in line with SAHPRA and ISO requirements.
• Analyse and report on regional compliance performance, identifying trends, root causes, and proactive corrective actions.
• Drive CAPA processes, conduct root cause analysis, and verify closure effectiveness at branch level.
• Coordinate and verify training implementation for all staff under area of responsibility, ensuring competency alignment with SOP and regulatory needs.
• Manage day-to-day operational compliance issues, ensuring immediate containment, communication, and resolution to maintain business continuity.
• Maintain and update compliance records and systems; enforce GDP
• Identify, implement, and monitor compliance improvement initiatives and verify effectiveness of corrective measures.
• Support branches in adhering to IMS standards; track completion of compliance actions, escalate overdue items. (ISO 9001, 14001, 45001, SAHPRA).
• Manage and enforce all pharmaceutical compliance requirements across dedicated branches and clients in line with GDP, GWP, SAHPRA, and ISO standards.
• Ensure adherence to requirements such as validation and calibration of temperature- controlled equipment, cold chain integrity, contamination control, pest management, and secure handling of high-scheduled and sensitive medicines.

Minimum Requirements :

Required Knowledge :

Required Skills :

Required Competencies :