Job Description
Vacancy: QA Compliance Clerk
Cape Town
Permanent | Full-Time
An established manufacturing company is seeking a QA Compliance Clerk to oversee key quality performance areas, including Change Control management, equipment calibrations, and GMP/QMS compliance. The role reports directly to the Quality Assurance Manager.
Key Performance Areas:
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Coordinate and manage Change Controls to ensure all proposed changes are properly documented, assessed for impact, and approved in line with established procedures.
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Oversee the progress of change control activities to ensure timely and effective implementation across departments.
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Facilitate cross-functional communication between QA, R&D, Production, and other teams to ensure all stakeholders are informed and aligned.
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Monitor and track change status, ensuring closure within defined timelines and compliance.
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Assist in coordinating and facilitating calibration and maintenance of equipment and utilities.
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Conduct internal and supplier audits as per GMP and ISO requirements.
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Perform GMP walkabouts within the factory to ensure compliance and identify improvement areas.
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Assist with investigations, corrective actions, and root-cause problem solving.
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Conduct GMP personnel training, including new employee inductions.
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Support validation operations by conducting validation protocols, cleaning validations, and preparing reports aligned with the Validation Master Plan.
Qualifications & Experience:
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Grade 12 or NQF 4 equivalent.
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Relevant tertiary or Post Basic Pharmacist Assistant Qualification.
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Minimum 35 years experience in Quality Assurance within a manufacturing environment.
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Experience with Change Control management.
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Experience in internal and supplier auditing.
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Experience in calibrations.
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Validation experience advantageous.
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Knowledge and experience in ISO/PICS/GMP standards (e.g., ISO 9001/22716/SAHPRA).
Competencies:
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Excellent communication and report-writing skills.
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Ability to perform effectively under pressure while managing multiple responsibilities.
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Assertive, with the ability to drive results and meet deadlines.
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Strong accountability, ownership, and critical thinking.
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Dependable and hardworking with strong attention to detail.
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Team-oriented with the ability to collaborate across departments.
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Self-motivated and proactive.
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