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.
To oversee the testing of plasma-derived products bought from suppliers, to ensure quality and compliance with company standards.
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.