Parow: Quality Assurance: Compliance Clerk posted by O’Brien Recruitment

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 35 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.