Quality Assurance Specialist - Pharmaceuticals

Placements24; Bloemfontein; Hybrid; ZAR 480,000 - 720,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Generous leave

Training & certification

Safety-conscious environment

Job summary

Placements24 in South Africa seeks a detail-oriented Quality Assurance Specialist to uphold quality and regulatory compliance in pharmaceutical manufacturing in Welkom. You will develop, implement and maintain QMS, conduct audits and ensure processes meet GMP and SAHPRA standards to safeguard product integrity and patient safety.

The role requires a Bachelor's in Pharmacy or related science, at least three years in QA, strong documentation and CAPA experience, and collaboration with production,

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or a related field.
• Minimum 3 years in a QA role within the pharmaceutical industry.
• Strong GMP knowledge and familiarity with regulatory guidelines (FDA, SAHPRA).
• Experience with document control, audits and deviation management (CAPA).
• Excellent analytical, problem-solving and documentation skills.

Responsibilities

• Develop, implement, and maintain the QMS in accordance with GMP and regulatory standards.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
• Review and approve batch records, validation protocols, and other quality documents.
• Investigate deviations, non-conformances, and customer complaints, implementing CAPAs.
• Monitor and analyze quality metrics, identifying trends and areas for improvement.
• Collaborate with production, R&D, and regulatory affairs teams to resolve quality issues and ensure product release.

Skills

QMS

GMP

Audits

CAPA

Documentation

Analytical

Education

Bachelor's degree in Pharmacy or related science

Tools

TrackWise

Quality Management Software

Job description

About the Role

Our client is looking for a detail-oriented Quality Assurance Specialist to ensure the highest standards of quality and compliance within their pharmaceutical manufacturing operations in Welkom . You will be responsible for developing, implementing, and maintaining quality management systems, conducting audits, and ensuring all processes meet regulatory requirements. This role is critical to maintaining product integrity and patient safety. This is a fantastic opportunity for a quality-focused professional to contribute to a reputable company in the Free State , ensuring that every product leaving the facility meets stringent global standards through diligent oversight and continuous improvement initiatives.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP and regulatory standards.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
• Review and approve batch records, validation protocols, and other quality-related documents.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Monitor and analyze quality metrics, identifying trends and areas for improvement.
• Collaborate with production, R&D, and regulatory affairs teams to resolve quality issues and ensure product release.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 3 years of experience in a Quality Assurance role within the pharmaceutical industry.
• Strong understanding of Good Manufacturing Practices (GMP) , regulatory guidelines (e.g., FDA, SAHPRA), and quality control principles.
• Experience with quality systems, document control, audits, and deviation management.
• Excellent analytical, problem-solving, and documentation skills.

Benefits

• Competitive salary package and potential for annual bonuses.
• Comprehensive health insurance and retirement savings plan.
• Generous annual leave and paid sick days.
• Opportunities for advanced training and professional certification in quality assurance.
• A collaborative and safety-conscious work environment.