Active ‘Raw Biological Material’ Manager / Plasma Quality Manager

About

One of SA's leading pharmaceutical companies has an opportunity for an experienced (5+ years) Active ‘Raw Biological Material’ Manager / Plasma Quality Manager.

The position is at a senior and strategic level.

To manage the operational day-to-day QA compliance of the plasma laboratory.

Duties & Responsibilities

The role in a nutshell:

• Evaluation and approval of new plasma suppliers
• Review of epidemiological data from plasma suppliers, and update the plasma master file
• Testing and release of human plasma and its derivatives (active raw materials) procured from plasma suppliers
• Responsible for the smooth, efficient day-to-day operation of the Quality Active Raw Material (QARM) laboratory
• Ensure the Aseptic Filling Suite remains environmentally compliant

A full detailed job-spec is available on request.

Desired Experience & Qualification

Minimum Requirements

• M.Sc in Microbiological Science, Molecular Biology, Biochemistry, or related field (PhD degree preferred)
• 5 to 10 years as a Senior Manager in a quality or pharmaceutical environment.
• At least 5 years of Quality Control or Microbiology laboratory experience
• Working knowledge of GMP in: blood establishments, transfusion transmittable infections, plasma quality and safety, and related regulatory requirements preferred.
• Computer literacy: MS Office, SAP, LIMS
• Thorough understanding of cGMP, GLP and international pharmaceutical standards preferred.
• Audit experience an advantage.

Package & Remuneration

Salary negotiable and infleunced by specific qualificatiojs, and specific industry experience.

A salary range of around R100k ctc p/m, plus an annual bonus, is envisaged for this role.

(About R1,3 million package), negotiable.