Remote GMP QA Auditor with Supplier Audits

Placements24

Gqeberha

Hybrid

ZAR 700,000 - 1,100,000

Full time

5 days ago
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Benefits offered by this job

Health insurance
Home office setup allowance
Travel expense support
Professional development opportunities
Paid time off

Job summary

Placements24 seeks a diligent Quality Assurance Auditor for a predominantly remote role with travel to supplier sites and internal facilities in the Eastern Cape region. You will conduct internal and supplier audits to ensure GMP compliance, evaluate findings, and drive CAPA actions while supporting regulatory inspections.

The ideal candidate has 5+ years in QA/QC in pharma, strong report writing, and proficiency with GMP and ICH guidelines.

Qualifications

  • Bachelor’s degree required in a scientific discipline.
  • Minimum 5 years' QA/QC experience in pharma.
  • Proven GMP audit experience (internal and external).
  • GMP knowledge, ICH guidelines and regulatory frameworks.
  • Excellent report writing and documentation skills.

Responsibilities

  • Plan and execute internal audits of manufacturing processes, quality systems, and documentation.
  • Conduct supplier audits to assess compliance with cGMP and contractual requirements.
  • Evaluate audit findings, prepare comprehensive audit reports, and recommend CAPA.
  • Follow up on CAPA implementation and verify effectiveness.
  • Ensure compliance with national and international regulatory standards (e.g., SAHPRA, FDA, EMA).
  • Participate in regulatory inspections and support the preparation of responses.
  • Develop and maintain audit checklists and procedures.
  • Stay current with evolving GMP regulations and industry best practices.
  • Provide training to internal staff on quality assurance principles and audit processes.
  • Contribute to the continuous improvement of the Quality Management System.

Skills

GMP audits
Audit planning
Analytical thinking
Report writing
Regulatory communication
Time management

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific discipline

Tools

Microsoft Office Suite

Job description

Placements24 seeks a diligent Quality Assurance Auditor for a predominantly remote role with travel to supplier sites and internal facilities in the Eastern Cape region. You will conduct internal and supplier audits to ensure GMP compliance, evaluate findings, and drive CAPA actions while supporting regulatory inspections.

The ideal candidate has 5+ years in QA/QC in pharma, strong report writing, and proficiency with GMP and ICH guidelines.

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