Quality Assurance Specialist - Pharmaceutical

Placements24; Rustenburg; Hybrid; ZAR 350,000 - 550,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

Training opportunities

Retirement plan

Job summary

Placements24 seeks a diligent Quality Assurance Specialist at its Rustenburg facility to strengthen the quality management system for pharmaceutical manufacturing. The role focuses on ensuring all products meet stringent quality standards and regulatory compliance throughout the process.

You will develop, implement, and maintain QA procedures, conduct audits, investigate deviations, and support CAPA activities while training staff on GMP principles and quality systems.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• Minimum 3 years of experience in a Quality Assurance role within pharma.
• Strong knowledge of GMP, regulatory guidelines and QMS.
• Experience with audits, deviation investigations and CAPA management.
• Excellent analytical, problem-solving and documentation skills.
• Proficiency with quality management software and standard office apps.

Responsibilities

• Develop, implement, and maintain QA policies and procedures in line with GMP/ISO standards.
• Conduct internal audits and inspections of manufacturing processes, documentation and facilities.
• Investigate deviations, customer complaints and CAPA, identifying root causes and corrective actions.
• Review and approve batch records, validation reports and change controls.
• Ensure compliance with local and international regulatory requirements.
• Provide training to personnel on quality systems and GMP principles.

Skills

Quality Assurance

GMP

CAPA management

Audits

Documentation

Root cause analysis

Quality management software

Analytical skills

Education

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

Tools

Quality Management Software

Job description

Our client is seeking a diligent and detail-oriented Quality Assurance Specialist to enhance their quality management system within their Rustenburg facility. This role is pivotal in ensuring that all pharmaceutical products meet stringent quality standards and regulatory compliance throughout the manufacturing process. You will be involved in developing, implementing, and maintaining quality assurance procedures, conducting audits, and investigating deviations. This is an excellent opportunity for a QA professional looking to make a significant impact in a company dedicated to producing high-quality medicines and maintaining the highest standards of patient safety, working within a culture that champions excellence and continuous improvement.

Key Responsibilities

• Develop, implement, and maintain quality assurance policies and procedures in accordance with regulatory standards (e.g., GMP, ISO).
• Conduct internal audits and inspections of manufacturing processes, documentation, and facilities.
• Investigate quality deviations, customer complaints, and non-conformances, determining root causes and implementing corrective and preventive actions (CAPAs).
• Review and approve batch records, validation reports, and change control documentation.
• Ensure compliance with all applicable local and international regulatory requirements.
• Provide training to personnel on quality systems and GMP principles.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 3 years of experience in a Quality Assurance role within the pharmaceutical industry.
• Strong knowledge of Good Manufacturing Practices (GMP), regulatory guidelines, and quality management systems.
• Experience with quality audits, deviation investigations, and CAPA management.
• Excellent analytical, problem-solving, and documentation skills.
• Proficiency in quality management software and standard office applications.

Benefits

• Competitive annual salary and performance incentives.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and company holidays.
• Opportunities for professional growth, training, and certification.
• Retirement fund contribution and life assurance.