QA Compliance Clerk

apartmentFrank Consult placeParow calendar_month 

A leading manufacturing environment is seeking a detail-driven QA Compliance Clerk to support key quality activities, including change control management, equipment calibrations and GMP/QMS compliance. This role is ideal for someone who thrives in a regulated environment, enjoys problem-solving, and is confident working across multiple departments.

Key Responsibilities
  • Coordinate and manage Change Controls, ensuring proper documentation, impact assessment and approval.
  • Track progress of change control activities and ensure timely implementation and closure.
  • Facilitate cross-functional communication between QA, R&D, Production and supporting departments.
  • Monitor and report on change status to ensure compliance.
  • Assist in coordinating equipment and utility calibrations and maintenance.
  • Conduct internal and supplier audits in line with GMP and ISO requirements.
  • Perform GMP walkabouts to identify compliance gaps and improvement areas.
  • Support investigations, corrective actions and root cause analysis.
  • Conduct GMP training and onboarding for new employees.
  • Support validation activities, including protocol execution, cleaning validation and reporting.
Competencies
  • Strong written and verbal communication skills.
  • Ability to manage multiple tasks under pressure.
  • Assertiveness and the confidence to drive timelines and outcomes.
  • Accountability, ownership and dependable work ethic.
  • Critical thinking and strong attention to detail.
  • Ability to collaborate and work effectively across departments.
  • Self-motivated and proactive.
Qualifications & Experience
  • Grade 12 or NQF 4 equivalent.
  • Relevant tertiary qualification or Post Basic Pharmacist Assistant qualification.
  • 3–5 years’ Quality Assurance experience in a manufacturing environment.
  • Experience in change control management.
  • Experience conducting internal and supplier audits.
  • Experience with calibration processes.
  • Validation experience advantageous.
  • Strong knowledge of ISO / PIC/S / GMP standards (e.g. ISO 9001, ISO 22716, SAHPRA).
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