Job Description

The Role

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.

Skills and Experience

Minimum Requirements:

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Matric (Grade 12) Tertiary qualification in Safety, Health, Environment, or Quality Minimum of 3-5 years' experience in compliance or SHEQ-related role or Responsible Pharmacist. Minimum of 1 - 3 experiences with SHEQ standards and ISO management systems (ISO 9001, 14001, 45001) or SAHPRA Exposure to audits, compliance reporting, or ISO management systems Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint). Experience with compliance or reporting systems (e.g., my SHEQ or equivalent) (advantageous) Relevant pharmaceutical compliance qualifications (e.g., GDP/GWP, validations, etc) (advantageous).

Required Knowledge:

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Understanding of compliance processes, policies, and Familiarity with document control principles, risk assessments, and CAPA Awareness of audit preparation and evidence General knowledge of training and competency alignment

Required

Skills:

Strong administrative and organisational Ability to collect, consolidate, and present data in structured Excellent verbal and written communication Skilled in tracking actions, following up, and ensuring completion of Analytical thinking with attention to Ability to multitask across multiple branches and

Other

Required Competencies:

Working knowledge of Good Distribution Practice Familiarity with Good Documentation Practice Basic understanding of risk management, change management, and CAPA Ability to interpret and apply company SOPs and compliance Relevant compliance-related training or tertiary qualification will be advantageous.


Job Reference: RTT74058