Pharmaceutical Quality Assurance Auditor - Upington

Placements24; Upington; On-site; ZAR 350,000 - 550,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Auditor training

Professional development

Job summary

Placements24 in Upington is seeking a thorough Pharmaceutical Quality Assurance Auditor to join our compliance team. Based in Upington, you will conduct internal and external audits of manufacturing sites, laboratories, and distribution channels to ensure GMP, GDP, and other quality standards are met.

You will prepare audit reports with findings and CAPAs, follow up on corrective actions, and stay updated on regulatory requirements.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• Minimum of 4 years of experience in pharmaceutical QA or QC, with auditing focus.
• In-depth knowledge of cGMP and GDP regulations and guidelines.
• Experience in conducting audits and preparing audit reports.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills.

Responsibilities

• Plan and execute internal and external audits of manufacturing facilities, quality control laboratories, and distribution centers.
• Assess compliance with cGMP, GDP, and other applicable regulatory requirements and company policies.
• Prepare comprehensive audit reports detailing findings, non-conformities, and CAPA recommendations.
• Follow up on the implementation and effectiveness of CAPAs.
• Stay current with evolving regulatory requirements and industry best practices.
• Contribute to the continuous improvement of the QMS.

Skills

Auditing

Regulatory knowledge

Analytical thinking

Education

Bachelors in Pharmacy/ Chemistry/ Biotechnology

Job description

About the Role

Our client is seeking a thorough and diligent Pharmaceutical Quality Assurance Auditor to join their compliance team, based in Upington. This role is critical for ensuring that our client's operations consistently meet the highest standards of quality and regulatory compliance. You will conduct internal and external audits of manufacturing sites, laboratories, and distribution channels to assess adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant quality standards. Your work will directly contribute to the safety and efficacy of the pharmaceutical products our client brings to market.

Key Responsibilities

• Plan and execute internal and external audits of manufacturing facilities, quality control laboratories, and distribution centers.
• Assess compliance with cGMP, GDP, and other applicable regulatory requirements and company policies.
• Prepare comprehensive audit reports detailing findings, non-conformities, and recommendations for corrective and preventive actions (CAPAs).
• Follow up on the implementation and effectiveness of CAPAs to ensure resolution of audit findings.
• Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
• Contribute to the continuous improvement of the Quality Management System (QMS).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• Minimum of 4 years of experience in pharmaceutical quality assurance or quality control, with a significant portion focused on auditing.
• In-depth knowledge of cGMP and GDP regulations and guidelines.
• Experience in conducting audits and preparing audit reports.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills, with the ability to present findings clearly and professionally.

Benefits

• Competitive salary and potential for annual bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer contributions.
• Opportunities for professional development, including auditor training and certifications.
• A crucial role contributing to product quality and patient safety in the Upington region.