Quality Assurance Specialist - Pharmaceuticals

Placements24; Rustenburg; On-site; ZAR 540,000 - 780,000; Full time

Benefits offered by this job

Competitive salary

Healthcare benefits

Retirement fund

Professional development opportunities

Job summary

Placements24 has an exciting opportunity for a Quality Assurance Specialist at our pharmaceutical manufacturing partner in Rustenburg. The role focuses on upholding quality, safety, and regulatory compliance across products.

You will develop and maintain the QMS, conduct audits, investigate deviations, and drive CAPA. The ideal candidate has GMP experience, strong analytical skills, and excellent communication to support patient safety in the North West province.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Biology, or related science.
• Minimum 3 years' experience in QA/QC in pharmaceutical manufacturing.
• Strong GMP knowledge and regulatory guidelines (FDA/EMA).
• Excellent analytical, problem-solving, and decision-making abilities.
• Proficiency in documentation review and auditing techniques.
• Strong written and verbal communication skills.

Responsibilities

• Develop, implement, and maintain the QMS in line with GMP and regs.
• Conduct internal and external audits of processes, facilities, and docs.
• Investigate deviations and OOS, implement CAPA.
• Review and approve batch records, validation protocols, and docs.
• Monitor quality data to identify trends and areas for improvement.
• Provide training on quality standards, GMP, and procedures.

Skills

GMP knowledge

Auditing

CAPA

QMS development

Documentation review

Analytical skills

Communication skills

Education

Bachelor of Science in Chemistry/Pharmacy/Biology

Job description

About the Role

Our client has an exciting opportunity for a dedicated Quality Assurance Specialist within their pharmaceutical manufacturing facility in Rustenburg . This role is fundamental to ensuring that all manufactured products meet the highest standards of quality, safety, and efficacy, in strict adherence to regulatory requirements. You will be instrumental in developing, implementing, and maintaining the company's quality management system, conducting audits, and resolving quality-related issues. The ideal candidate will possess a strong understanding of GMP principles and a keen eye for detail, contributing to the company's commitment to excellence and patient well-being in the North West province .

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP and regulatory standards.
• Conduct internal and external audits of manufacturing processes, facilities, and documentation to ensure compliance.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
• Review and approve batch records, validation protocols, and other quality-related documents.
• Monitor and analyze quality control data to identify trends and areas for improvement.
• Provide training to personnel on quality standards, GMP requirements, and specific procedures.

Requirements

• Bachelor's degree in Chemistry, Pharmacy, Biology, or a related scientific discipline.
• Minimum of 3 years of experience in a Quality Assurance or Quality Control role within the pharmaceutical industry .
• Strong knowledge of Good Manufacturing Practices (GMP), regulatory guidelines (e.g., FDA, EMA), and quality systems.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in documentation review and auditing techniques.
• Strong written and verbal communication skills.

Benefits

• Competitive annual salary and performance-based bonuses.
• Comprehensive healthcare benefits, including medical aid and retirement fund.
• Opportunities for professional development and advanced training in quality management.
• A stable and secure work environment within a reputable pharmaceutical company.
• Contribution to ensuring the safety and efficacy of essential medicines.