Quality Assurance: Compliance Clerk

1 week ago

Cape Town, Western Cape, South Africa O'Brien Recruitment Full time

Quality Assurance: Compliance Clerk

We are seeking a dedicated individual to assist in maintaining and improving Quality Management System (QMS) compliance with relevant ISO, SAHPRA, and SANS standards, as well as other applicable international and national regulations. The successful candidate will report to the Quality Assurance Manager.

Key Responsibilities:

  • Ensure timely updates of new Standard Operating Procedures (SOPs), records, and amendments on the QMS portal to reflect current practices in accordance with relevant SOPs.
  • Manage equipment calibration to align with the master calibration schedule and complete calibrations on time each month.
  • Collaborate with accredited and potential suppliers to secure cost-effective services without compromising quality standards.
  • Assist in aligning organisational processes with the current QMS and applicable regulatory requirements.
  • Monitor document compliance across the organisation to maintain consistency with established standards.
  • Support corrective actions and root cause analyses for audit findings, non-compliance issues, and calibration discrepancies.
  • Conduct internal and external supplier audits in line with the established audit schedule.
  • Deliver GMP induction training for new employees.
  • Oversee training compliance across the organisation, ensuring employees hold the required certifications and competencies.

Qualifications and Experience:

  • Matric and a relevant tertiary qualification.
  • 2-3 years of experience in a Quality Assurance or Production environment.
  • Experience in calibrations.
  • Advantageous: Experience in conducting internal and supplier audits.
  • Proficient in creating, drafting, and editing Standard Operating Procedures.
  • Knowledge and experience with ISO/PICS/GMP standards (e.g., ISO 9001/22716/SAHPRA).

This position offers an opportunity to contribute significantly to the organisation's commitment to quality and compliance.

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