QUALITY ASSURANCE ASSISTANT

Purpose of the Role

The QA Assistant supports the Quality Assurance team in maintaining product quality, (medicines and medical devices), compliance with regulations, and adherence to standard operating procedures.

Key Responsibilities

• Support quality inspections and testing of products and components.
• Maintain quality records, inspection reports and test results.
• Ensure compliance with quality policies, procedures and industry regulations.
• Work with production teams to identify and resolve quality issues.
• Assist with calibration of QA testing equipment.
• Support quality-control training initiatives.
• Assist with external audit preparation and documentation.
• Manage retained samples and product records.
• Assist with customer and supplier complaint investigations.
• Support sterilisation documentation and Certificates of Conformance (CoCs).
• Assist with equipment and process qualification and validation activities.
• Perform clean-room inspections and housekeeping checks.
• Carry out administrative duties including data capture, scanning and document control.

Requirements

High school diploma or equivalent.

ISO 13485 training certificates and

basic SAHPRA regulatory awareness will be advantageous.

Minimum 3 years experience in quality control or a related environment preferred.

Skills & Competencies

Attention to detail; analytical thinking; problem-solving; strong written and verbal communication; teamwork; proficiency in Outlook, SharePoint and Microsoft Office applications.