Pharmaceutical Quality Assurance Specialist

Placements24; Rustenburg; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary package

Health insurance

Retirement savings plan

Life insurance

Training and development

Stable work environment

Job summary

Placements24 is seeking a Pharmaceutical Quality Assurance Specialist to join the Rustenburg team. The role focuses on ensuring quality across the product lifecycle, performing audits, reviewing documentation, and driving CAPA and process improvements.

You will work with the QA team to maintain GMP compliance, support regulatory inspections, and contribute to continuous quality enhancements in a leading pharmaceutical manufacturer.

Qualifications

• Bachelor’s degree in a relevant science field required.
• Minimum 4 years of QA experience in pharma industry.
• Solid understanding of GMP and SAHPRA/regulatory guidelines.
• Experience with CAPA, deviations, and QMS documentation.

Responsibilities

• Conduct internal audits of manufacturing processes and systems for GMP compliance.
• Review and approve batch records and validation protocols.
• Investigate deviations and OOS results; implement CAPA actions.
• Support external regulatory audits and inspections with proper documentation.
• Lead quality improvement initiatives and maintain QMS procedures.
• Update training materials and ensure ongoing QA compliance.

Skills

GMP knowledge

CAPA

QMS experience

Audit experience

Regulatory liaison

Education

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

Tools

Quality management systems

Job description

About the Role

Our client seeks a detail-oriented and experienced Pharmaceutical Quality Assurance Specialist to join their vital quality team in Rustenburg . This role is crucial for ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be involved in various QA activities, including audits, documentation review, and process improvement initiatives. This is an excellent opportunity for a professional dedicated to maintaining the highest quality benchmarks in a demanding yet rewarding industry, contributing to the safety and efficacy of medications produced by a leading pharmaceutical manufacturer.

Key Responsibilities

• Conduct internal audits of manufacturing processes, documentation, and quality systems to ensure compliance with GMP and regulatory standards.
• Review and approve batch records, validation protocols, and other critical quality-related documents.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
• Participate in external audits and inspections by regulatory authorities, providing necessary documentation and support.
• Develop and implement quality improvement initiatives to enhance operational efficiency and product quality.
• Maintain and update quality management system procedures and training materials as required.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 4 years of experience in Quality Assurance within the pharmaceutical industry.
• Thorough understanding of Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., SAHPRA).
• Experience with quality management systems, deviation management, and CAPA processes.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent written and verbal communication skills for documentation and interdepartmental collaboration.

Benefits

• Competitive salary package with regular reviews and potential for annual bonuses.
• Comprehensive health, dental, and vision insurance benefits.
• Company-sponsored retirement savings plan and life insurance.
• Ongoing training and development opportunities to enhance your QA expertise.
• A stable and supportive work environment focused on quality and compliance.