Quality Assurance Specialist

Placements24; Rustenburg; Hybrid; ZAR 480,000 - 640,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Paid time off

Professional growth opportunities

Job summary

Placements24 in Rustenburg, South Africa, seeks a Quality Assurance Specialist to uphold GMP-compliant QA throughout manufacturing. The role focuses on implementing QMS, conducting audits, and driving CAPA programs to ensure product quality and patient safety.

Requirements include a relevant science degree and 4+ years in pharmaceutical QA/QC with strong GMP knowledge. The position supports a remote-friendly environment within Rustenburg and offers growth opportunities.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field.
• Minimum 4 years of pharmaceutical QA/QC experience.
• Strong GMP knowledge and regulatory understanding.

Responsibilities

• Develop, implement, and maintain the site's Quality Management System (QMS).
• Conduct internal audits and participate in external regulatory inspections and customer audits.
• Review and approve batch records, deviation reports, and change control documents.
• Investigate quality incidents, implement CAPAs, and track effectiveness.
• Ensure compliance with GMP, SOPs, and applicable regulatory requirements.
• Provide QA training to manufacturing and relevant personnel.

Skills

Attention to detail

Analytical skills

Documentation skills

Communication skills

Education

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

Job description

About the Role

Our client is seeking a detail-oriented Quality Assurance Specialist to join their pharmaceutical manufacturing team in Rustenburg . This role is crucial for maintaining the highest standards of product quality and regulatory compliance throughout the manufacturing lifecycle. You will be responsible for developing, implementing, and monitoring quality systems, ensuring adherence to Good Manufacturing Practices (GMP) and other relevant industry standards. This position offers a fantastic opportunity to contribute to product integrity and patient safety in a dynamic manufacturing environment, promoting a culture of quality consciousness and continuous improvement across all operations.

Key Responsibilities

• Develop, implement, and maintain the site's Quality Management System (QMS).
• Conduct internal audits and participate in external regulatory inspections and customer audits.
• Review and approve batch records, deviation reports, and change control documents.
• Investigate quality incidents, implement corrective and preventive actions (CAPAs), and track their effectiveness.
• Ensure compliance with GMP , SOPs, and other applicable regulatory requirements.
• Provide quality assurance training to manufacturing and other relevant personnel.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
• Minimum of 4 years of experience in pharmaceutical Quality Assurance or Quality Control.
• In-depth knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
• Experience with audit procedures, deviation management, and CAPA systems.
• Strong analytical skills and attention to detail.
• Excellent documentation and communication skills, suitable for a remote work environment within Rustenburg .

Benefits

• Competitive annual salary and potential for annual bonuses.
• Comprehensive health, dental, and vision insurance benefits.
• Paid time off, including vacation, sick days, and public holidays.
• Opportunities for professional growth and development in the pharmaceutical QA field.
• A proactive quality-focused culture that values attention to detail in Rustenburg .