Senior Scientist

SUMMARY:
Knowledge of cGMP (SA, PIC, WHO) and GLP guidelines.

POSITION INFO:

Our client a developer and manufacturer of affordable quality human vaccine for Africa and the world''s needs is looking for a Senior Scientist. The successful incumbent will hold a PhD or MSc with at least 2 years’ experience in relevant discipline.

Experience & industry accreditation/ knowledge Required:

• 2 Years’ experience in analytical method development of vaccine / biotech / pharmaceutical industry or equivalent would be advantageous.
• 1 Year supervisory experience in product development or a cGMP environment.
• Exposure and understanding of scientific principles that governs production of vaccines and /or biologicals.
• Quality & regulatory compliance knowledge, i.e. MCC and WHO.
• GDP and IP management knowledge preferable.
• Experience in technology transfer would be advantageous.
• Knowledge of cGMP (SA, PIC, WHO) and GLP guidelines.
• Experience in having faced successfully local quality audits would be an advantage.

Technical Competencies required to perform this aspect of the role:

• Risk Management
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
• Scientific/ Technical report writing.
• Good working knowledge of Microsoft office
• Quality management Systems
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Documentation Management
• Inventory Management
• Environmental, Health & Safety Management
• Statistical Trending & Data Analysis
• Metric Development & Report Writing
• Coaching & Mentoring of peers & staff
• Quality Management
• Building own, team and site’s GMP Knowledge and Compliance
• Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
• Participate in building a sustainable Quality Culture and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
• Ensure Deviations, Change Controls, CAPAs are handled effectively.
• Advocate continuous improvement within own department as well as cross functionally.

NB! This job is now closed. You can apply for other jobs by uploading your CV.