Hybrid Senior QA Auditor — GMP & Compliance Leader

Placements24; Gqeberha; Hybrid; ZAR 420,000 - 600,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid leave

Job summary

Placements24 seeks a Senior Quality Assurance Auditor to join a distinguished pharmaceutical manufacturer in Port Elizabeth, Eastern Cape. The role supports hybrid work, combining remote flexibility with on-site responsibilities.

The incumbent will conduct internal and external audits of facilities, systems, and processes to ensure GMP compliance and regulatory alignment, driving CAPA and continuous quality improvement.

Qualifications

• Bachelor's degree in a relevant scientific field.
• Minimum 4 years in Quality Assurance or Quality Control in pharma with auditing focus.
• Strong knowledge of cGMP regulations (FDA, EMA, SAHPRA) and ICH guidelines.
• Proven experience conducting internal and external audits.
• Excellent analytical, problem-solving and report-writing skills.

Responsibilities

• Plan, conduct, and document internal and external audits of manufacturing sites, contract manufacturers, and suppliers.
• Assess compliance with cGMP, ICH guidelines, and other regulatory requirements.
• Evaluate effectiveness of quality management systems including document control, change control, CAPA, and deviation management.
• Prepare comprehensive audit reports detailing findings and recommendations for corrective actions.
• Follow up on audit findings to ensure timely CAPA implementation.
• Participate in regulatory inspections and support audit teams.
• Develop and refine audit plans and checklists based on risk assessments and regulatory changes.
• Provide training on quality assurance and GMP compliance.

Skills

Auditing

GMP knowledge

cGMP

Quality Systems

Regulatory compliance

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology

Tools

Microsoft Office

Job description

Placements24 seeks a Senior Quality Assurance Auditor to join a distinguished pharmaceutical manufacturer in Port Elizabeth, Eastern Cape. The role supports hybrid work, combining remote flexibility with on-site responsibilities.

The incumbent will conduct internal and external audits of facilities, systems, and processes to ensure GMP compliance and regulatory alignment, driving CAPA and continuous quality improvement.