Quality Assurance Specialist - Pharmaceutical Manufacturing

Placements24; Soweto; Hybrid; ZAR 400,000 - 640,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Flexible work arrangement

Job summary

Placements24 seeks a detail‑oriented Quality Assurance Specialist in Soweto to oversee GMP‑compliant QA/QC activities. You will conduct internal audits, review batch records, and support regulatory inspections in a hybrid work setting.

The ideal candidate has a solid GMP background, strong analytical skills, and the ability to work independently and within a team to ensure product quality and regulatory compliance.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related science.
• Minimum 3 years in Quality Assurance or Quality Control within the pharmaceutical industry.
• Thorough knowledge of GMP and relevant regulatory guidelines.
• Experience with QMS documentation, batch record review, and deviation management.
• Strong analytical, problem-solving, and organizational skills.

Responsibilities

• Implement and maintain the Quality Management System (QMS) in line with GMP guidelines.
• Conduct internal audits of manufacturing processes, QA procedures, and documentation.
• Review and approve batch records, deviation reports, and change controls.
• Investigate deviations and OOS results, perform root cause analysis and CAPAs.
• Assist in qualification and validation of equipment and processes.
• Support regulatory inspections and customer audits.

Skills

GMP knowledge

QA/QC experience

Analytical skills

Documentation

Microsoft Office

Education

Bachelor's degree in science

Tools

QMS documentation

Job description

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking a detail-oriented Quality Assurance Specialist to join their team, operating on a hybrid model within the vibrant Soweto area. You will be integral in ensuring that all pharmaceutical products manufactured meet stringent quality standards and comply with regulatory requirements. This role involves overseeing various quality assurance processes, conducting internal audits, reviewing documentation, and supporting external regulatory inspections. The ideal candidate will possess a solid understanding of Good Manufacturing Practices (GMP), a meticulous approach to quality control, and excellent analytical skills. This is an excellent opportunity for a QA professional to contribute to the production of safe and effective medicines within a well-established pharmaceutical company, enjoying the benefits of a hybrid work environment that balances collaboration and flexibility.

Key Responsibilities

• Implement and maintain the Quality Management System (QMS) in accordance with GMP guidelines.
• Conduct internal audits of manufacturing processes, quality control procedures, and documentation.
• Review and approve batch records, deviation reports, and change controls.
• Participate in the investigation of deviations and out-of-specification results, ensuring root cause analysis and implementation of corrective and preventive actions (CAPAs).
• Support the qualification and validation of equipment and processes.
• Assist in the preparation for and hosting of regulatory inspections and customer audits.
• Ensure all quality-related documentation is accurate, complete, and maintained according to regulatory requirements.
• Train personnel on GMP principles and quality assurance procedures.
• Monitor quality metrics and contribute to continuous improvement initiatives.
• Release finished products upon satisfactory review of batch records and quality data.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Thorough knowledge of Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
• Experience with QMS documentation, batch record review, and deviation management.
• Strong understanding of pharmaceutical manufacturing processes.
• Excellent analytical, problem-solving, and organizational skills.
• Good written and verbal communication skills.
• Ability to work effectively both independently and as part of a team.
• Proficiency in Microsoft Office Suite.
• Attention to detail and a commitment to quality.

Benefits

This hybrid Quality Assurance Specialist role offers a competitive salary, comprehensive medical aid benefits, and retirement fund contributions. Our client provides excellent opportunities for professional development and career advancement within the pharmaceutical sector. You'll benefit from a flexible work arrangement, allowing for productive remote work and valuable in-office collaboration. This position in Soweto offers a stable and rewarding career path in pharmaceutical quality assurance.