Active Raw Material (ARM) Quality Manager

National Bioproducts Institute NPC; Durban; On-site; ZAR 500 000 - 700 000; Full time

Job summary

A leading biopharmaceutical company in Durban seeks an experienced Active Raw Material Quality Manager. This role involves evaluating plasma suppliers, ensuring compliance with cGMP, and managing daily operations of the QARM laboratory. The successful candidate will oversee testing and release processes and implement an environmental monitoring program. Applicants should have relevant experience and qualifications.

Qualifications

• Rigorous evaluation and approval of new plasma suppliers.
• Review of epidemiological data from plasma suppliers.
• Testing and release of human plasma and derivatives.

Responsibilities

• Ensure compliance with local and international guidelines.
• Manage daily operations of the QARM laboratory.
• Implement the formal environmental monitoring program.

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.

Responsibilities

National Bioproducts Institute NPC has a vacancy for the role of a Active Raw Material (ARM) Quality Manager. The successful incumbent will be responsible for:

• Rigorous evaluation and approval of new plasma suppliers in line with NBI specifications and local and international guidelines.
• Review of epidemiological data and other data from plasma suppliers and updating NBI’s plasma master file on an annual basis.
• Testing and release of human plasma and its derivatives (active raw materials) procured from plasma suppliers, adhering to sound scientific principles and complying with current good manufacturing practice (cGMP).

Further, the Plasma Quality Manager is responsible for the smooth, efficient day‑to‑day operation of the Quality Active Raw Material (QARM) laboratory, providing operational assurance in support of business and strategic requirements. Lastly, the Plasma Quality Manager is responsible for NBI’s formal environmental monitoring program, through monitoring production environments, including NBI’s aseptic filling suite, to ensure the environments comply with regulations.

Applications are invited from suitably qualified and experienced candidates.