SUMMARY:
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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
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Coordinate and manage Change Controls, ensuring proper documentation, impact assessment and approval.
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Track progress of change control activities and ensure timely implementation and closure.
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Facilitate cross-functional communication between QA, R&D, Production and supporting departments.
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Monitor and report on change status to ensure compliance.
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Assist in coordinating equipment and utility calibrations and maintenance.
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Conduct internal and supplier audits in line with GMP and ISO requirements.
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Perform GMP walkabouts to identify compliance gaps and improvement areas.
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Support investigations, corrective actions and root cause analysis.
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Conduct GMP training and onboarding for new employees.
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Support validation activities, including protocol execution, cleaning validation and reporting.
Competencies
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Strong written and verbal communication skills.
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Ability to manage multiple tasks under pressure.
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Assertiveness and the confidence to drive timelines and outcomes.
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Accountability, ownership and dependable work ethic.
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Critical thinking and strong attention to detail.
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Ability to collaborate and work effectively across departments.
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Self-motivated and proactive.
Qualifications & Experience
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Grade 12 or NQF 4 equivalent.
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Relevant tertiary qualification or Post Basic Pharmacist Assistant qualification.
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3–5 years’ Quality Assurance experience in a manufacturing environment.
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Experience in change control management.
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Experience conducting internal and supplier audits.
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Experience with calibration processes.
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Validation experience advantageous.
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Strong knowledge of ISO / PIC/S / GMP standards (e.g. ISO 9001, ISO 22716, SAHPRA).
