Quality Assurance Systems Lead

National Bioproducts Institute NPC; Durban; On-site; ZAR 600,000 - 800,000; Full time

Job summary

The National Bioproducts Institute NPC is seeking a Quality Assurance (QA) Systems Lead to enhance compliance and quality standards. This position involves leading the QA team, coordinating audits, and driving continuous improvements in line with regulatory requirements, ensuring excellence in Quality Assurance practices.

Qualifications

• Experience in leading QA departments and ensuring compliance.
• Familiarity with industry standards and regulatory requirements.
• Proven skills in audit coordination and quality metrics reporting.

Responsibilities

• Lead technical initiatives in the QA department to maintain compliance.
• Coordinate annual audits and manage QA processes effectively.
• Implement continuous improvement measures within the QA systems.

Skills

cGMP

ISO13485

Quality Management Systems (QMS)

Auditing

Risk Assessment

Continuous Improvement

Job description

Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI’s vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.

Required

National Bioproducts Institute NPC has a vacancy for the role of Quality Assurance (QA) Systems Lead. The successful incumbent will be required to:

Ensure excellence in the Quality Assurance department by leading technical initiatives and maintaining compliance with industry standards through:

Requirements

Ensuring excellence in the QA department and organizational compliance with cGMP, ISO13485, and regulatory requirements by:

• Coordinating the annual internal, external, and vendor audit programs, including planning, executing, and reporting.
• Implementing and managing systems and tools.
• Planning and conducting process risk assessments.
• Documenting and processing all changes at NBI.
• Controlling all documents and records effectively.
• Maintaining, reporting, and regularly reviewing QMS systems, processes, and procedures aligned with QA objectives and industry standards.
• Identifying and reporting quality metrics for each system during review meetings and forums.
• Implementing continuous improvement measures within the QA department.

Applications are invited from suitably qualified and experienced candidates.