Quality Coordinator

2 weeks ago


Bellville, Western Cape, South Africa Progressive International - Global Recruitment #miningjobs #engineeringjobs #Remotejobs #financejobs Full time

The primary function of a Quality & Validation Coordinator, the Safety, Health and Environment Coordinator (SHE Coordinator), is to implement and maintain the Quality Assurance program of the plant. The secondary function of the Quality & Validation Coordinator is to lead, maintain, and implement the validation program of the plant.

Qualification And Experience

  • Matric
  • Diploma in a Quality or Science field (Analytical Chemistry, Biotechnology, Microbiology, or equivalent)
  • Microsoft Office proficiency
  • 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 audits, 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.
  • Assist with training material and training records.
  • 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.
  • LEVEL OF DECISION MAKING: Moderate to Minimal, with significant decisions related to validation requiring higher-level approvals.
Desired Skills
  • Quality assurance
  • Quality inspections
  • Regulatory compliance
  • SAHPRA
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