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Quality Assurance : Compliance Clerk

Quality Assurance : Compliance Clerk

O'Brien RecruitmentParow, Western Cape, South Africa
2 days ago
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 :

  • 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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    Quality Assurance Clerk • Parow, Western Cape, South Africa