Quality Assurance: Compliance Clerk

3 weeks ago

Cape Town, South Africa O'Brien Recruitment Full time

Vacancy: QA Compliance ClerkCape TownPermanent | Full-TimeAn 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:Coordinate and manage Change Controls to ensure all proposed changes are properly documented, assessed for impact, and approved in line with established procedures.Oversee the progress of change control activities to ensure timely and effective implementation across departments.Facilitate cross-functional communication between QA, R&D, Production, and other teams to ensure all stakeholders are informed and aligned.Monitor and track change status, ensuring closure within defined timelines and compliance.Assist in coordinating and facilitating calibration and maintenance of equipment and utilities.Conduct internal and supplier audits as per GMP and ISO requirements.Perform GMP walkabouts within the factory to ensure compliance and identify improvement areas.Assist with investigations, corrective actions, and root-cause problem solving.Conduct GMP personnel training, including new employee inductions.Support validation operations by conducting validation protocols, cleaning validations, and preparing reports aligned with the Validation Master Plan.Qualifications & Experience:Grade 12 or NQF 4 equivalent.Relevant tertiary or Post Basic Pharmacist Assistant Qualification.Minimum 3–5 years’ experience in Quality Assurance within a manufacturing environment.Experience with Change Control management.Experience in internal and supplier auditing.Experience in calibrations.Validation experience advantageous.Knowledge and experience in ISO/PICS/GMP standards (e.g., ISO 9001/22716/SAHPRA).Competencies:Excellent communication and report-writing skills.Ability to perform effectively under pressure while managing multiple responsibilities.Assertive, with the ability to drive results and meet deadlines.Strong accountability, ownership, and critical thinking.Dependable and hardworking with strong attention to detail.Team-oriented with the ability to collaborate across departments.Self-motivated and proactive.

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