Quality Assurance Specialist - GMP

About the Role

Our client is looking for a meticulous Quality Assurance Specialist with strong Good Manufacturing Practice (GMP) knowledge to join their team in Port Elizabeth . This role is essential for ensuring that all pharmaceutical manufacturing processes and products adhere to the highest quality standards and regulatory requirements. You will be involved in quality system management, batch record review, deviation investigations, and audit support. This hybrid position allows for effective integration of remote work capabilities with necessary on-site activities, providing a balanced and productive work experience. You will contribute to maintaining product integrity and patient safety through rigorous quality oversight.

Key Responsibilities

• Review and approve batch manufacturing records, ensuring compliance with GMP and approved procedures.
• Investigate deviations, Out-of-Specification (OOS) results, and CAPA effectiveness, recommending and implementing corrective actions.
• Participate in internal and external audits, supporting audit readiness and responding to audit findings.
• Assist in the qualification and validation activities for equipment, processes, and analytical methods.
• Ensure adherence to company Quality Management System (QMS) policies and procedures.
• Provide training to manufacturing personnel on GMP principles and quality-related topics as needed.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related science field.
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or related regulated industry.
• Solid understanding of GMP regulations and quality management systems.
• Experience with batch record review, deviation management, and CAPA systems.
• Strong attention to detail, analytical skills, and problem-solving abilities.
• Comfortable working in a hybrid model, demonstrating adaptability and effective communication.

Benefits

• Competitive annual salary and potential for performance bonuses.
• Comprehensive health and retirement benefits.
• Hybrid work model that combines remote flexibility with essential on-site responsibilities in Port Elizabeth .
• Opportunities for professional development and training in pharmaceutical quality assurance.
• A supportive team environment focused on quality and compliance.

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