SUMMARY:
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 S...
POSITION INFO:
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:
Lead compliance implementation and resolution across region:
- Lead regional compliance performance by implementing and verifying operational controls, ensuring timely closure of nonconformances, and maintaining continuous audit readiness.
Own operational compliance management:
- Manage operational compliance requirements across branches, direct corrective actions, and provide guidance to ensure full adherence to policies, SOPs, and regulatory standards.
Ensure audit and inspection readiness in line with Statutory and regulatory requirements:
- Ensure all sites remain audit-ready by managing document control, reviewing records, and coordinating evidence packs in line with SAHPRA and ISO requirements.
Compile and interpret compliance data:
- Analyse and report on regional compliance performance, identifying trends, root causes, and proactive corrective actions.
Manage and verify CAPA implementation:
- Drive CAPA processes, conduct root cause analysis, and verify closure effectiveness at branch level.
Lead Risk Change Management:
- Facilitate risk assessments, verify implementation of change controls, and ensure mitigation measures are documented and maintained.
Oversee compliance training and competency:
- Coordinate and verify training implementation for all staff under area of responsibility, ensuring competency alignment with SOP and regulatory needs.
Ensure operational compliance continuity:
- Manage day-to-day operational compliance issues, ensuring immediate containment, communication, and resolution to maintain business continuity.
Systems Documentation Maintenance:
- Maintain and update compliance records and systems; enforce GDP disciplines.
- Identify, implement, and monitor compliance improvement initiatives and verify effectiveness of corrective measures.
Compliance Implementation (ISO Pharma):
- Support branches in adhering to IMS standards; track completion of compliance actions, escalate overdue items. (ISO 9001, 14001, 45001, SAHPRA).
Pharmaceutical Compliance and Operational Management:
- 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.
- Collaborate with operations to maintain regulatory standards in daily activities, home-patient deliveries, and specialised pharma services.
- Represent RTT in client-facing compliance meetings and external audits, ensuring evidence readiness, issue resolution, and sustained client trust.
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Minimum Requirements:
- Matric (Grade 12) essential.
- Tertiary qualification in Safety, Health, Environment, or Quality Management.
- 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 beneficial.
- 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:
- Understanding of compliance processes, policies, and procedures.
- Familiarity with document control principles, risk assessments, and CAPA processes.
- Awareness of audit preparation and evidence requirements.
- General knowledge of training and competency alignment processes.
Required Skills:
- Strong administrative and organisational skills.
- Ability to collect, consolidate, and present data in structured reports.
- Excellent verbal and written communication skills.
- Skilled in tracking actions, following up, and ensuring completion of tasks.
- Analytical thinking with attention to detail.
- Ability to multitask across multiple branches and priorities.
Required Competencies:
- Working knowledge of Good Distribution Practice requirements.
- Familiarity with Good Documentation Practice standards.
- Basic understanding of risk management, change management, and CAPA processes.
- Ability to interpret and apply company SOPs and compliance requirements.
- Relevant compliance-related training or tertiary qualification will be advantageous.
