QA Compliance Clerk

SUMMARY:
-

POSITION INFO:

A leading manufacturing environment is seeking a detail-driven QA Compliance Clerk to support key quality activities, including change control management, equipment calibrations and GMP/QMS compliance. This role is ideal for someone who thrives in a regulated environment, enjoys problem-solving, and is confident working across multiple departments.

Key Responsibilities

• Coordinate and manage Change Controls, ensuring proper documentation, impact assessment and approval.

• Track progress of change control activities and ensure timely implementation and closure.

• Facilitate cross-functional communication between QA, R&D, Production and supporting departments.

• Monitor and report on change status to ensure compliance.

• Assist in coordinating equipment and utility calibrations and maintenance.

• Conduct internal and supplier audits in line with GMP and ISO requirements.

• Perform GMP walkabouts to identify compliance gaps and improvement areas.

• Support investigations, corrective actions and root cause analysis.

• Conduct GMP training and onboarding for new employees.

• Support validation activities, including protocol execution, cleaning validation and reporting.

Competencies

• Strong written and verbal communication skills.

• Ability to manage multiple tasks under pressure.

• Assertiveness and the confidence to drive timelines and outcomes.

• Accountability, ownership and dependable work ethic.

• Critical thinking and strong attention to detail.

• Ability to collaborate and work effectively across departments.

• Self-motivated and proactive.

Qualifications & Experience

• Grade 12 or NQF 4 equivalent.

• Relevant tertiary qualification or Post Basic Pharmacist Assistant qualification.

• 3–5 years’ Quality Assurance experience in a manufacturing environment.

• Experience in change control management.

• Experience conducting internal and supplier audits.

• Experience with calibration processes.

• Validation experience advantageous.

• Strong knowledge of ISO / PIC/S / GMP standards (e.g. ISO 9001, ISO 22716, SAHPRA).