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Active Raw Material Quality Manager
Job summary
A leading quality management firm in Durban is seeking a Quality Manager to ensure the quality, safety, and efficacy of products. The candidate will evaluate plasma suppliers, review epidemiological data, and manage the QARM laboratory's operations. Ideal qualifications include an MSc in a relevant field, a minimum of 5 years in quality control, and experience in regulatory compliance. Strong communication and people management skills are essential for success. The position offers an opportunity to lead quality initiatives in a dynamic environment.
Qualifications
- Minimum of 5 years experience in quality control or a microbiological laboratory.
- Experience as a senior staff manager in a quality or pharmaceutical environment.
- Working knowledge of GMP in blood establishments.
Responsibilities
- Evaluate and approve new plasma suppliers according to specifications.
- Review epidemiological data and update the plasma master file annually.
- Test and release human plasma and derivatives following cGMP.
Skills
Education
The ARM Quality Manager reports to the Head : Quality Management and Scientific Affairs and will be responsible for contributing to the quality, safety, and efficacy of the companys products through rigorous evaluation and approval of new plasma suppliers in line with the companys specifications and local and international guidelines; reviewing epidemiological data and other data from plasma suppliers and updating the companys plasma master file on an annual basis; testing and releasing 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); being 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; and being responsible for the companys formal environmental monitoring program, through monitoring production environments, including the aseptic filling suite, ensuring the environments comply with regulations.
Key Requirements : MSc in Microbiological Science, Molecular Biology, Biochemistry, or a related field, with a PhD degree preferred.
A minimum of 5 years experience in quality Control or a Microbiological laboratory and years experience as a senior staff manager in a quality or pharmaceutical environment.
Working knowledge of GMP in blood establishments, transfusion transmittable infections, plasma quality and safety, and related regulatory requirements; a thorough understanding of cGMP, GLP, and international pharmaceutical standards preferred; and hands-on experience with internal and supplier audits will be advantageous.
Additional Requirements : Strong oral and written communication, people managements and development, problem solving, quality awareness, attention to detail and analytical, quantitative analysis, relationship management, and personal leadership skills.
Additionally, the ideal candidate should have statistical knowledge, the ability to work independently, but also in a team, and business impact.
- Only candidates that meet all the requirements should apply
- Only candidates that are shortlisted will be contacted
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* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.