Pharmaceutical Quality Assurance Auditor

Placements24; Noord-Kaap; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement fund

Life assurance

Paid time off

Professional development

Job summary

Placements24 is seeking a highly skilled Pharmaceutical Quality Assurance Auditor to join the team in Kimberley. The role involves conducting internal and external audits to ensure GMP compliance and company policies, with responsibility for CAPAs and audit reporting.

The ideal candidate will have a pharmacy/chemistry/biology background, 4+ years in QA/QC in pharma, and strong analytical and writing skills to uphold product quality and regulatory standards.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Extensive knowledge of GMP, ICH guidelines, and regulatory audit principles.
• Experience in conducting audits and assessing quality systems.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent report writing and communication skills.

Responsibilities

• Plan, conduct, and document internal and external quality audits of manufacturing sites, suppliers, and contract organizations.
• Evaluate compliance with cGMP, GDP, and other relevant regulatory guidelines and industry best practices.
• Identify non-conformities, assess their impact, and recommend appropriate corrective and preventive actions (CAPAs).
• Follow up on CAPAs to ensure effective implementation and closure.
• Prepare audit reports summarizing findings, observations, and recommendations.
• Contribute to the continuous improvement of the company's Quality Management System.

Skills

Audit Management

Regulatory Knowledge

Quality Assurance

Analytical Thinking

Education

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

Job description

About the Role

Our client is seeking a highly skilled Pharmaceutical Quality Assurance Auditor to join their team in Kimberley . This critical role involves conducting internal and external audits to ensure compliance with pharmaceutical quality standards, regulatory requirements (such as GMP), and company policies. You will be responsible for assessing processes, identifying areas of non-compliance, and recommending corrective and preventive actions (CAPAs). Your expertise will be crucial in maintaining the integrity and quality of our client's pharmaceutical products and operations.

Key Responsibilities

• Plan, conduct, and document internal and external quality audits of manufacturing sites, suppliers, and contract organizations.
• Evaluate compliance with cGMP, GDP, and other relevant regulatory guidelines and industry best practices.
• Identify non-conformities, assess their impact, and recommend appropriate corrective and preventive actions (CAPAs).
• Follow up on CAPAs to ensure effective implementation and closure.
• Prepare audit reports summarizing findings, observations, and recommendations.
• Contribute to the continuous improvement of the company's Quality Management System.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Extensive knowledge of GMP, ICH guidelines, and regulatory audit principles.
• Experience in conducting audits and assessing quality systems.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent report writing and communication skills.

Benefits

• Competitive salary and annual bonus structure.
• Comprehensive health insurance coverage.
• Retirement fund and life assurance benefits.
• Paid time off and opportunities for professional development.
• Work in a quality-focused environment with a reputable pharmaceutical organization.