About the Role

Our client, a distinguished player in the pharmaceutical industry, is seeking a highly experienced Senior Quality Assurance Auditor to join their robust quality management team in Kimberley, Northern Cape . This critical role involves conducting internal and external audits to ensure compliance with Good Manufacturing Practices (GMP), Positive Clinical Practices (GCP), and other relevant regulatory standards. You will play a vital part in maintaining the integrity and quality of our client's pharmaceutical products and operations. The ideal candidate will possess extensive auditing experience, a deep understanding of pharmaceutical quality systems, and strong analytical and interpersonal skills. This is an excellent opportunity to contribute to a company dedicated to upholding the highest standards of quality and safety.

Key Responsibilities

- Plan, schedule, and conduct internal and external audits of manufacturing sites, contract research organizations (CROs), and other relevant suppliers.
- Assess compliance with GMP, GCP, GLP, and other applicable regulatory requirements.
- Prepare comprehensive audit reports detailing findings, observations, and recommendations for corrective actions.
- Follow up on audit findings to ensure timely and effective implementation of corrective and preventive actions (CAPAs).
- Contribute to the development and maintenance of the company's Quality Management System (QMS).
- Participate in regulatory inspections and provide support as needed.
- Stay current with evolving global regulatory requirements and industry best practices related to quality assurance and auditing.




- Provide training and guidance to internal personnel on quality and compliance matters.
- Evaluate the effectiveness of quality systems and identify areas for improvement.
- Collaborate with various departments to promote a strong quality culture throughout the organization.

Requirements

- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 5 years of experience in Quality Assurance or Auditing within the pharmaceutical industry.
- Demonstrated expertise in conducting GMP and/or GCP audits.
- In-depth knowledge of pharmaceutical quality systems and regulatory compliance.
- Familiarity with a wide range of pharmaceutical manufacturing processes and laboratory operations.
- Excellent analytical, critical thinking, and problem-solving skills.
- Strong report writing and communication abilities, with meticulous attention to detail.
- Ability to travel domestically and internationally as required for audits.
- Proven ability to work independently and manage multiple audit projects effectively.
- Experience working in or with operations in the Northern Cape region is advantageous.

Benefits

- Our client offers a competitive salary.
- A comprehensive benefits package including health insurance, retirement contributions, and performance-related bonuses.
- Opportunities for continuous professional development, including advanced auditing certifications and training, are readily available.
- This role operates on a hybrid basis, offering flexibility in work arrangements, and is based in Kimberley, Northern Cape .
- Join a reputable company committed to excellence in quality and patient safety.

📌 Senior Quality Assurance Auditor (Canada)
🏢 Placements24
📍 Canada