Senior Quality Assurance Auditor

Placements24; Kimberley; Hybrid; CAD 38,000 - 64,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Performance bonuses

Job summary

Placements24 is seeking a Senior Quality Assurance Auditor to join a leading pharmaceutical client in Kimberley. The role focuses on planning and executing GMP/GCP audits of sites, CROs, and suppliers to ensure regulatory compliance and robust CAPA processes.

The ideal candidate has 5+ years in QA or auditing within pharma, strong knowledge of quality systems, and excellent analytical and communication skills. Hybrid work with travel is required.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology or a related scientific discipline.
• Minimum of 5 years of QA or auditing experience in the pharmaceutical industry.
• Demonstrated expertise in GMP and/or GCP audits.

Responsibilities

• Plan, schedule, and conduct internal and external audits of manufacturing sites, CROs, and other relevant suppliers.
• Assess compliance with GMP, GCP, GLP and other regulatory requirements.
• Prepare comprehensive audit reports detailing findings and recommendations for CAPAs.
• Follow up on audit findings to ensure timely and effective CAPAs.
• Contribute to the development and maintenance of the company’s QMS.

Skills

GMP/GCP auditing

Quality Management

Regulatory compliance

Audit reporting

Education

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

Job description

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), Good 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.