Quality Assurance Systems Lead

Neptune; Durban; On-site; ZAR 300,000 - 400,000; Full time

Job summary

A leading African biopharmaceutical company in Durban is seeking a Quality Assurance Systems Lead. The successful candidate will ensure excellence in QA operations, lead audits, and maintain compliance with cGMP and ISO13485 standards. Ideal for those with experience in managing quality management systems and a commitment to continuous improvement.

Qualifications

• Proven experience in Quality Assurance and compliance with cGMP, ISO13485.
• Experience in leading audits and managing quality management systems.

Responsibilities

• Lead technical initiatives in the QA department.
• Coordinate internal, external, and vendor audit programs.
• Maintain compliance with industry standards and document all changes.

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.

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 departmental operations by leading technical initiatives and maintaining compliance with industry standards through :

Ensuring excellence in the Quality Assurance (QA) department and organisational compliance with cGMP, ISO13485 and regulatory requirements, through effective performance of quality management (QMS) functions by :

• Co-ordinating the annual internal, external and vendor audit programmes, through planning, executing and reporting.
• Implementation and management of systems and tools.
• Ensure that process risk assessments are planned and conducted.
• Ensure all changes at NBI are documented and processed.
• Ensure all documents and records are effectively controlled.
• The maintenance, reporting and frequent review of the various QMS systems, processes and procedures that are in keeping with the QA department objectives and industry standards.
• Identifying and reporting on quality metrics for each system at review meetings and forums.
• Implementing continuous improvement measures in the QA department.

Applications are invited from suitably qualified and experienced candidates.