Quality Coordinator

7 days ago


Cape Town, Western Cape, South Africa Progessive International Full time
QUALIFICATION AND EXPERIENCE
  • Matric
  • Diploma in a Quality or Science field (Analytical Chemistry, Biotechnology, Microbiology, or equivalent)
  • Microsoft Office proficiency
    • Business Skills:
      • Basic Mechanical knowledge
      • Knowledge of regulations and compliance (GMP, SAHPRA, WHO, FDA, etc.)
      Quality Management
      • Administer and maintain non-conformance and quality management systems, including Corrective and Preventative Action (CAPA), Non-conformance Report (NCR), change control and deviations.
      • Ensure quality requirements are met by both internal and external audit, review of inspection reports and analysis of non-conformance reporting.
      • Assist in vendor/contractor performance monitoring and ensure only appropriate vendors/contractors are utilized.
      • Ensure quality plans are produced when required and meet regulatory requirements.
      • Monitor and maintain internal quality standards.
      • Assist with CAPA close -out for self-inspections.
      • Assit with training material and training record.
      • Document and maintain Quality records..
      • Other quality-related duties as assigned by the Line- Manager.
      Validation Lead Responsibilities (20%)
      • Develop and maintain the Validation Master Plan (VMP).
      • Lead and execute validation activities for processes, equipment, utilities, and cleaning validation.
      • Develop and review validation protocols (IQ, OQ, PQ) and reports.
      • Conduct risk assessments related to validation and ensure all validation activities are compliant with regulatory requirements.
      • Ensure requalification and periodic validation review of critical systems and processes.
      • Coordinate validation activities with production, engineering, and quality teams.
      • Address deviations, CAPAs, and change control related to validation.
      • Maintain validation documentation in compliance with regulatory expectations.
      • Support audits and inspections by providing validation documentation and evidence.
      Impact of Errors
      • Non-compliance with safety regulations can lead to significant legal and financial consequences, including fines and operational disruptions.
  1. LEVEL OF DECISION MAKING
  • Moderate to Minimal, with significant decisions related to validation requiring higher-level approvals.


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