Pharmaceutical Quality Assurance Auditor

Placements24; LegKraal Gate; On-site; ZAR 480,000 - 780,000; Full time

Benefits offered by this job

Medical plans and retirement benefits

Professional development and audit培训

Audit training opportunities

Job summary

Placements24 seeks an experienced Pharmaceutical Quality Assurance Auditor to join the compliance team in Mahikeng. You will conduct internal and external GMP audits, assess manufacturing processes and documentation, and drive CAPAs to uphold product integrity and patient safety.

The ideal candidate has a Bachelor's degree in a scientific discipline, 5+ years in QA/QC auditing, and strong knowledge of GMP regulations. Join a company dedicated to excellence in the pharmaceutical industry.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical Quality Assurance or Quality Control, with significant auditing experience.
• In-depth knowledge of GMP regulations (SAHPRA, FDA, EMA) and Quality Management Systems.
• Strong understanding of pharmaceutical manufacturing processes and laboratory operations.
• Excellent analytical, critical thinking, and report-writing skills.

Responsibilities

• Plan, execute, and report on internal audits of manufacturing processes, quality systems, and documentation to assess compliance with GMP and regulatory requirements.
• Participate in external audits of suppliers, contract manufacturers, and other third parties involved in the pharmaceutical supply chain.
• Identify non-compliance issues, assess risks, and develop recommendations for corrective and preventive actions (CAPAs).
• Follow up on audit findings to ensure that CAPAs are implemented effectively and timely.
• Assist in preparing for regulatory inspections by health authorities.
• Contribute to the continuous improvement of the company's Quality Management System (QMS).

Education

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

Job description

About the Role

Our client is seeking a detail-oriented and experienced Pharmaceutical Quality Assurance Auditor to join their compliance team in Mahikeng. This critical role involves conducting internal and external audits to ensure that manufacturing facilities, processes, and systems comply with Good Manufacturing Practices (GMP) and other relevant regulatory standards. You will play a key part in maintaining the company's high standards of quality and regulatory compliance, safeguarding product integrity and patient safety. This position offers the chance to contribute significantly to the company's commitment to excellence in the pharmaceutical industry.

Key Responsibilities

• Plan, execute, and report on internal audits of manufacturing processes, quality systems, and documentation to assess compliance with GMP and regulatory requirements.
• Participate in external audits of suppliers, contract manufacturers, and other third parties involved in the pharmaceutical supply chain.
• Identify non-compliance issues, assess risks, and develop recommendations for corrective and preventive actions (CAPAs).
• Follow up on audit findings to ensure that CAPAs are implemented effectively and timely.
• Assist in preparing for regulatory inspections by health authorities.
• Contribute to the continuous improvement of the company's Quality Management System (QMS).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical Quality Assurance or Quality Control, with significant experience in auditing.
• In-depth knowledge of GMP regulations (e.g., SAHPRA, FDA, EMA) and Quality Management Systems.
• Strong understanding of pharmaceutical manufacturing processes and laboratory operations.
• Excellent analytical, critical thinking, and report-writing skills.

Benefits

• Competitive salary and comprehensive benefits package, including medical and retirement plans.
• Opportunities for professional development and specialized audit training.
• Exposure to diverse aspects of pharmaceutical quality and compliance.
• A professional and ethical work environment.
• Play a vital role in ensuring product quality and patient safety.