Active Raw Material Quality Manager

About the role

The pharmaceutical company seeks an Active Raw Material Quality Manager to ensure the safety, quality and efficacy of plasma‑derived products. The role oversees supplier evaluation, plasma testing, laboratory operations and the company’s environmental monitoring programme.

Key responsibilities

• Evaluate and approve new plasma suppliers against company specifications, local and international guidelines.
• Review epidemiological data, update the plasma master file annually and compile submissions for SAHPRA.
• Manage the Quality Active Raw Material (QARM) laboratory, coordinating testing, staff activities and timely release of raw materials.
• Oversee SAP and LIMS transactions, ensuring data integrity for material release.
• Lead validation activities (IQ, OQ, PQ) for new analytical methods and equipment, and support CAPEX requests.
• Coordinate environmental monitoring, define critical control points and perform trend analysis of microbiological results.

Required skills

• Current Good Manufacturing Practice (cGMP) knowledge.
• Proficiency with SAP and LIMS systems.
• Experience in method validation (IQ, OQ, PQ) and equipment qualification.
• Risk modeling and epidemiological data analysis.
• Environmental monitoring and microbiological trend analysis.