Quality Assurance Auditor

Placements24; Queenstown; Hybrid; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Home office allowance

Travel expenses for audits

Health insurance

Retirement savings plan

Professional development

Flexible remote work

Job summary

Placements24 is seeking an experienced Quality Assurance Auditor to join a remote team serving the Eastern Cape region from Queenstown. The role focuses on ensuring GMP compliance across manufacturing facilities, contract manufacturers and suppliers, and driving CAPA initiatives to improve product quality.

The ideal candidate holds a Bachelor's degree in a scientific field and has at least four years of QA/QC experience in the pharmaceutical industry, with strong audit, analytical, and

Qualifications

• Minimum of 4 years in Quality Assurance or Quality Control within the pharmaceutical industry.
• Proven experience conducting audits and managing CAPA processes.
• Strong analytical, problem-solving and decision-making skills.
• Excellent report writing and communication abilities; able to work independently and collaboratively.

Responsibilities

• Plan and conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to assess GMP compliance.
• Prepare detailed audit reports with findings, non-conformities, and improvement recommendations.
• Follow up on audit findings to ensure CAPAs are implemented effectively.
• Review and approve quality-related documentation such as SOPs, validation protocols, and change controls.
• Participate in regulatory inspections and support inspection teams.
• Contribute to continuous improvement of the Quality Management System (QMS).

Skills

Quality Assurance

Auditing

GMP Knowledge

CAPA Management

Analytical Skills

Report Writing

Education

Bachelor's degree in Pharmacy/Chemistry/Engineering or related

Job description

About the Role

Our client is seeking an experienced and rigorous Quality Assurance Auditor to join their remote team, serving the Eastern Cape region from Queenstown . This role is critical for ensuring that manufacturing facilities, processes, and quality systems comply with Good Manufacturing Practices (GMP) and other relevant regulatory standards. You will conduct internal and external audits, identify areas of non-compliance, and work with teams to implement corrective actions. This is an excellent opportunity for a quality professional to make a significant impact on product quality and compliance within the pharmaceutical sector, from a flexible remote setting.

Key Responsibilities

• Plan and conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to assess GMP compliance.
• Prepare detailed audit reports, documenting findings, non-conformities, and recommendations for improvement.
• Follow up on audit findings to ensure timely and effective implementation of corrective and preventive actions (CAPAs).
• Review and approve quality-related documentation, such as SOPs, validation protocols, and change controls.
• Participate in regulatory inspections and provide support to inspection teams.
• Contribute to the continuous improvement of the Quality Management System (QMS).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related scientific discipline.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP), relevant regulatory guidelines (e.g., SAHPRA, ICH), and quality systems.
• Proven experience in conducting audits and managing CAPA processes.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent report writing, communication, and interpersonal skills, with the ability to work independently and collaboratively.

Benefits

• Competitive annual salary and potential for performance bonuses.
• Comprehensive health insurance and retirement savings plan.
• Allowance for home office setup and travel expenses for audits.
• Opportunities for professional development and advanced training in quality assurance.
• Flexible remote work arrangement, contributing to a healthy work-life balance.
• A critical role in maintaining product quality and compliance for a respected pharmaceutical company.