SUMMARY:
-
POSITION INFO:
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:
-
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.
