Senior Qa&Ra Specialist | Medtech | Gauteng. Temp To Permanent Vacancy.

Salesworx Recruitment (Pty) Ltd; Gauteng; On-site; ZAR 300 000 - 400 000; Full time

Job summary

A recruitment agency in Johannesburg is seeking a Senior QA & RA Specialist to ensure compliance with CQA processes. The ideal candidate will have over 3 years of experience in quality and regulatory fields, with a Pharmacy degree and fluency in English and Afrikaans. The role involves managing product surveillance, conducting audits, and liaising with regulatory authorities. This position offers a contract with basic salary and travel allowance.

Benefits

Basic salary

Travel allowance

Qualifications

• At least 3 years of professional experience in quality and regulatory fields.
• At least 2 years as a Pharmacist.
• Good knowledge of GMP, GDP, and ISO.

Responsibilities

• Ensure compliance of CQA processes including complaint management.
• Manage product surveillance for medicinal products and medical devices.
• Coordinate corrective actions and communicate with regulatory bodies.
• Implement and audit management of Quality System aligned with ISO.
• Proactively monitor national regulatory requirements and manage approvals.

Skills

Quality Assurance

Regulatory Affairs

Pharmacy knowledge

Fluent in English

Fluent in Afrikaans

Strong communication skills

Organizational skills

Multitasking

Stress resistance

Team player

Education

Pharmacy Degree

Job description

Overview

Senior QA & RA Specialist - MedTech, Gauteng Location : Johannesburg, Gauteng, South Africa Employment type : Contract (6-month temporary contract with possibility of permanent employment) Senior QA & RA Specialist responsible for ensuring compliance of CQA processes within the region, including complaint management, product surveillance, supplier / distributor controls, regulatory affairs, and QA system implementation.

Responsibilities

Local Complaint Coordinator activity : establish and maintain processes for logging, investigating, notifying authorities, training staff, closing complaints, and ensuring backup training.

Product Surveillance for Medicinal Products and Medical Devices : gather, record, transmit adverse events, report to authorities, maintain surveillance system, and coordinate with functional teams.

Field Action execution : coordinate corrective actions, communicate with Ministry of Health and customers, ensure timely execution, reconciliation, closure, and backup training.

Distributor & Supplier QA : manage assessment program, conduct audits, supervise corrective actions, train distributors, sign QA agreements, and maintain approved supplier list.

Implementation and audit management of Quality System in the region, ensuring alignment with ISO

• , ISO
• , Corporate Quality Manual and change control procedures.

NCR, CAPA and Change Management : investigate non-conformances, initiate corrective and preventive actions, and manage change control process.

Regulatory Development : proactively monitor national regulatory requirements, develop approval strategies, maintain good standing with regulators, and manage product registration life cycle.

Training: maintain training records, train employees on quality systems, GDP, and SAHPRA guidelines.

Compliance & Documentation : implement SOPs, manage preparation of new SOPs, ensure documentation meets Corporate Quality Manual and ISO standards.

ERP System SME : expert on JDE / ERP distribution aspects, ensure backup training, and maintain region-appropriate processes.

Other quality aspects : manage temperature-controlled shipments, maintain critical task backups, define and control quality aspects of third‑party warehouses, and establish sample rooms.

Regulatory Affairs : annual product submission plan, oversee registration dossiers, liaison with authorities, manage post-registration variations, coordinate inspections, and manage correspondence.

Qualifications

At least 3 years of professional experience in quality and regulatory fields; at least 2 years as a Pharmacist.

Pharmacy Degree required.

Good knowledge of GMP, GDP, ISO

Fluent in English and Afrikaans.

Strong communication, organizational, and multitasking skills; stress resistant; team player; self‑motivated with high initiative.

Ability to liaise with stakeholders across functions and regulators.

Benefits

Basic salary and travel allowance.