Quality Assurance Auditor (Pharmaceuticals)

Placements24; Queenstown (MD); On-site; USD 33,000 - 45,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Life insurance

Annual bonus

Wellness program

Professional development

Job summary

Placements24 seeks an experienced Quality Assurance Auditor for its client in Queenstown, Eastern Cape. The role requires conducting internal and external GMP audits, evaluating findings, and driving CAPAs to improve the quality management system and regulatory compliance.

The ideal candidate will have a Bachelor's in a scientific field and at least 4 years in pharmaceutical QA/QC or auditing, with strong analytical and reporting skills and willingness to travel for external audits.

Qualifications

• Bachelor's degree in a scientific field as listed
• Minimum 4 years' experience in pharmaceutical QA, QC, or auditing
• Deep knowledge of GMP regulations (SAHPRA, FDA, EMA) and QMS
• Experience conducting GMP internal and external audits
• Strong analytical and communication skills

Responsibilities

• Plan, conduct, and report internal GMP audits
• Participate in supplier and contract manufacturer audits
• Evaluate findings, identify non-conformities, and recommend CAPAs
• Follow up CAPAs and verify effectiveness
• Review validation protocols and reports
• Contribute to the development and improvement of the QMS
• Stay current with GMP regulations and best practices
• Provide audit training and guidance to staff
• Prepare audit reports with findings and risks
• Maintain audit records per procedures and regulations

Skills

Auditing

GMP knowledge

QMS

CAPA

Analytical skills

Report writing

Travel readiness

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering

Tools

Audit management tools

Job description

About the Role

Our client, a major pharmaceutical manufacturer, is seeking an experienced Quality Assurance Auditor to join their compliance team. The role is based in Queenstown, Eastern Cape , and requires a hands‑on approach to ensuring adherence to stringent quality standards across all operations. The successful candidate will be responsible for conducting internal and external audits of manufacturing facilities, processes, and quality systems to ensure compliance with Good Manufacturing Practices (GMP) and relevant regulatory requirements. This position is critical for maintaining the integrity and quality of our client's pharmaceutical products. We are looking for an individual with a sharp eye for detail, a thorough understanding of quality management systems, and the ability to drive continuous improvement initiatives within a pharmaceutical manufacturing environment.

Key Responsibilities

• Plan, conduct, and report on internal audits of manufacturing processes, quality systems, and documentation to assess compliance with GMP and regulatory standards.
• Participate in external audits of suppliers, contract manufacturers, and other third parties.
• Evaluate audit findings, identify non-conformities, and recommend corrective and preventive actions (CAPAs).
• Follow up on CAPA implementation and verify their effectiveness.
• Review and approve validation protocols and reports as part of the audit process.
• Contribute to the development and improvement of the company's quality management system (QMS).
• Stay current with evolving GMP regulations and industry best practices.
• Provide training and guidance to internal staff on quality assurance principles and audit procedures.
• Prepare audit reports summarizing findings, risks, and recommendations.
• Maintain audit records and documentation in accordance with company procedures and regulatory requirements.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific discipline.
• A minimum of 4 years of experience in pharmaceutical Quality Assurance, Quality Control, or Auditing.
• In-depth knowledge of GMP regulations (e.g., SAHPRA, FDA, EMA) and quality management systems.
• Proven experience in conducting GMP audits, both internal and external.
• Strong understanding of pharmaceutical manufacturing processes, validation, and quality control.
• Excellent analytical, problem-solving, and critical thinking skills.
• High level of accuracy and attention to detail.
• Effective report writing and communication skills.
• Ability to work independently, manage multiple audit assignments, and meet deadlines.
• Proficiency in standard office software and familiarity with audit management tools is an advantage.
• Willingness to travel occasionally for external audits.

Benefits

• Our client offers a competitive salary package, including medical aid, retirement fund contributions, and life insurance.
• Professional development opportunities are available through internal and external training programs.
• This role is based full-time in Queenstown, Eastern Cape , offering a stable and focused work environment.
• We foster a culture of quality and compliance.
• Additional benefits include annual performance bonuses and employee wellness programs.