Quality Assurance Specialist - GMP Compliance

Placements24; Polokwane; Vor Ort; ZAR 550.000 - 750.000; Vollzeit

Zusammenfassung

Placements24 is seeking a detail-oriented Quality Assurance Specialist for our client in Polokwane, Limpopo. The role focuses on upholding GMP compliance across manufacturing and QA processes, developing and maintaining quality systems, and ensuring regulatory adherence for pharmaceutical products at our Polokwane site.

The position requires a 3+ year track record in QA/QC within pharma, strong documentation and communication skills, and the ability to work cross-functionally with production and

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related field.
• Minimum 3 years' experience in Quality Assurance or Quality Control in pharmaceutical manufacturing.
• Thorough understanding of GMP principles and SAHPRA guidelines.
• Experience with deviation management, CAPA, change control, and audits.
• Strong documentation and clear written/verbal communication.

Aufgaben

• Develop, implement, and maintain the Quality Management System (QMS) per GMP.
• Conduct internal audits of manufacturing, QC labs, and documentation for compliance.
• Review and approve batch records, validation protocols, and QA documents.
• Manage deviation investigations, CAPA, change control processes.
• Participate in regulatory inspections and audits by authorities.
• Deliver GMP training to relevant personnel.
• Monitor quality metrics, identify trends, and drive improvements.
• Collaborate with production, R&D, and other departments to resolve issues.

Kenntnisse

Attention to detail

Organizational skills

Communication skills

Team collaboration

Ausbildung

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

Tools

Quality management software

Office applications

Jobbeschreibung

About the Role

Our client, a reputable pharmaceutical manufacturing company, is seeking a detail-oriented Quality Assurance Specialist to join their operations in **Polokwane, Limpopo**. This role is essential for upholding the highest standards of Good Manufacturing Practice (GMP) compliance across all manufacturing and quality control processes. You will be responsible for developing, implementing, and maintaining quality systems, conducting internal audits, and ensuring adherence to regulatory requirements. This is a key position within our **Polokwane** facility, contributing directly to the quality and safety of our pharmaceutical products and ensuring compliance with national and international standards.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP regulations.
• Conduct internal audits of manufacturing processes, quality control laboratories, and documentation to ensure compliance.
• Review and approve batch records, validation protocols, and other quality-related documents.
• Manage deviation investigations, CAPA (Corrective and Preventive Actions) implementation, and change control processes.
• Participate in regulatory inspections and audits by external authorities.
• Develop and deliver GMP training programs to relevant personnel.
• Monitor and analyze quality metrics, identifying trends and implementing improvement initiatives.
• Ensure all quality-related activities are documented accurately and in a timely manner.
• Collaborate with production, R&D, and other departments to resolve quality issues and drive continuous improvement.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline.
• Minimum of 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical manufacturing industry.
• Thorough understanding of GMP principles and regulations (e.g., SAHPRA guidelines).
• Experience with quality systems, including deviation management, CAPA, change control, and audits.
• Strong knowledge of pharmaceutical manufacturing processes and analytical testing.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
• Effective written and verbal communication skills, with the ability to document clearly and concisely.
• Proficiency in using quality management software and standard office applications.
• Ability to work both independently and collaboratively within a team environment.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including medical aid, life insurance, and retirement fund contributions. We provide excellent opportunities for professional growth and career development within the quality assurance field. The role is based at our modern manufacturing facility in **Polokwane**. We are committed to fostering a culture of quality and continuous improvement, offering a supportive and challenging work environment. Join a team dedicated to producing high-quality pharmaceuticals.