Pharmaceutical Quality Assurance Auditor

Placements24; Soweto; Hybrid; ZAR 480,000 - 600,000; Full time

Job summary

Placements24 is seeking a Pharmaceutical Quality Assurance Auditor to join their quality unit in Soweto. The role focuses on ensuring GMP-compliant manufacturing processes, systems, and documentation, with audits conducted internally and externally.

The ideal candidate has a Pharmacy, Chemistry, or Life Sciences background, at least 4 years in QA/QC and 2 years auditing, and strong analytical and communication skills. Travel for external audits is required.

Qualifications

• Bachelor degree in Pharmacy, Chemistry, or Life Sciences.
• 4+ years in pharmaceutical quality assurance or QC.
• At least 2 years auditing experience.
• Knowledge of GMP, ICH Q7, WHO GMP.
• Strong auditing and reporting capabilities.
• Willingness to travel.

Responsibilities

• Plan and conduct internal audits of manufacturing ops to assess GMP compliance.
• Perform external audits of suppliers and contract manufacturers.
• Document audit findings and prepare recommendations for corrective actions.
• Follow up on corrective actions for timely resolution.
• Review and approve quality docs like batch records and change controls.
• Contribute to QMS continuous improvement.

Skills

GMP knowledge

Quality systems

Auditing

Analytical skills

Communication skills

Problem-solving

Education

Bachelor's degree in Pharmacy/Chemistry/Life Sciences

Job description

About the Role

Our client is seeking a highly qualified Pharmaceutical Quality Assurance Auditor to join their robust quality unit based in Soweto. This role is essential for ensuring that our client's manufacturing processes, systems, and documentation comply with regulatory standards and internal quality policies. You will conduct internal and external audits, identify areas for improvement, and drive corrective actions to maintain the highest levels of compliance and product quality. The ideal candidate will possess a strong understanding of GMP and quality systems, exceptional analytical skills, and the ability to conduct audits effectively and impartially.

Key Responsibilities

• Plan and conduct internal audits of manufacturing operations, laboratories, warehousing, and distribution systems to assess compliance with GMP and regulatory requirements.
• Perform external audits of suppliers, contract manufacturers, and other third-party service providers.
• Document audit findings, identify non-compliance issues, and develop detailed audit reports with clear recommendations for corrective actions.
• Follow up on corrective actions to ensure timely and effective implementation and resolution.
• Review and approve quality-related documentation, including batch records, validation reports, and change controls.
• Contribute to the continuous improvement of the Quality Management System (QMS).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in pharmaceutical quality assurance or quality control, with at least 2 years in an auditing role.
• Comprehensive knowledge of GMP regulations, guidelines (e.g., ICH Q7, WHO GMP), and quality management systems.
• Proven ability to plan, conduct, and report on audits effectively.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills, with the ability to interact professionally with auditees and management.
• Willingness to travel for external audits as required.

Benefits

• Competitive annual salary based on experience and qualifications.
• Comprehensive medical aid and retirement fund benefits.
• Opportunities for professional development, including lead auditor training.
• Generous annual leave entitlement.
• A challenging and rewarding role within a respected pharmaceutical organization in Soweto .