QA Compliance Clerk

2 weeks ago

Parow, Western Cape, South Africa Frank Consult Full time R250 000 - R400 000 per year

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).

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