Active Raw Material (ARM) Quality Manager, Durban

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 a Active Raw Material(ARM) Quality Manager. The successful incumbent will be responsible for:

Contributing to the quality, safety, and efficacy of NBI’s products through:

• Rigorous evaluation and approval of new plasma suppliers in line with NBI specifications and local and international guidelines, and
• Review of epidemiological data and other data from plasma suppliers and updating of NBI’s plasma master file on an annual basis, and
• 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.