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).