Pharmaceutical Quality Assurance Specialist

Placements24; Upington; On-site; ZAR 520,000 - 780,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Paid time off

Professional development

Job summary

Placements24 in Upington, Northern Cape seeks a Pharmaceutical Quality Assurance Specialist to uphold GMP, maintain the QMS, and ensure product safety and regulatory compliance. You will review records, manage CAPAs, and support internal and external audits.

Ideal candidates have 3+ years in pharma QA/QC, strong documentation skills, and the ability to work independently and in a team. This role focuses on quality systems, SOP adherence, and continuous improvement.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Thorough understanding of GMP, GCP, and other relevant pharmaceutical quality standards.
• Experience in reviewing batch records, deviations, and change controls.
• Strong knowledge of quality management systems and audit processes.
• Excellent attention to detail and accuracy in documentation.
• Good analytical and problem-solving skills.
• Effective written and verbal communication skills.

Responsibilities

• Assist in the development, implementation, and maintenance of the Quality Management System (QMS).
• Review and approve batch records, deviation reports, change controls, and CAPAs.
• Conduct internal audits and inspections to ensure compliance with GMP and company policies.
• Participate in external audits by regulatory agencies and customers, and assist in preparing responses.
• Monitor and ensure adherence to Standard Operating Procedures (SOPs) and relevant regulatory guidelines.
• Support vendor qualification and auditing processes.
• Manage product complaints and investigations, ensuring timely resolution.
• Contribute to the training of personnel on quality assurance principles and GMP requirements.
• Maintain quality-related documentation and records, ensuring accuracy and completeness.
• Stay up-to-date with current GMP regulations and industry best practices.

Skills

Quality Assurance

GMP compliance

Audits

Inspections

Documentation accuracy

Regulatory understanding

Education

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

Tools

Microsoft Office

Quality management software

Job description

About the Role

Our client, a respected pharmaceutical manufacturer, is seeking a detail-oriented Pharmaceutical Quality Assurance Specialist to join their dedicated team in Upington, Northern Cape. This role is fundamental in upholding the highest standards of quality and compliance across all pharmaceutical operations. You will be responsible for developing, implementing, and maintaining the Quality Management System (QMS), ensuring adherence to Good Manufacturing Practices (GMP) and other relevant regulatory requirements. This is a critical position for ensuring product safety, efficacy, and market authorization. The ideal candidate will possess a strong understanding of quality principles and a meticulous approach to ensuring regulatory compliance. You will contribute to the company's reputation for quality and reliability.

Key Responsibilities

• Assist in the development, implementation, and maintenance of the Quality Management System (QMS).


• Review and approve batch records, deviation reports, change controls, and CAPAs.


• Conduct internal audits and inspections to ensure compliance with GMP and company policies.


• Participate in external audits by regulatory agencies and customers, and assist in preparing responses.


• Monitor and ensure adherence to Standard Operating Procedures (SOPs) and relevant regulatory guidelines.


• Support vendor qualification and auditing processes.


• Manage product complaints and investigations, ensuring timely resolution.


• Contribute to the training of personnel on quality assurance principles and GMP requirements.


• Maintain quality-related documentation and records, ensuring accuracy and completeness.


• Stay up-to-date with current GMP regulations and industry best practices.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.


• Minimum of 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.


• Thorough understanding of GMP, GCP, and other relevant pharmaceutical quality standards.


• Experience in reviewing batch records, deviations, and change controls.


• Strong knowledge of quality management systems and audit processes.


• Excellent attention to detail and accuracy in documentation.


• Good analytical and problem-solving skills.


• Effective written and verbal communication skills.


• Ability to work independently and as part of a team.


• Proficiency in using Microsoft Office Suite and quality management software.

Benefits

• Our client offers a competitive salary, comprehensive benefits package including medical aid, retirement fund, and paid time off.


• Employees benefit from a stable and supportive work environment, opportunities for professional development, and exposure to a wide range of quality assurance activities.


• Our client is committed to employee growth and well-being.

Join our client's quality assurance team in Upington, Northern Cape and play a vital role in ensuring the integrity of pharmaceutical products.