The Pharmaceutical Quality Assurance program combines theoretical knowledge with hands-on skills in all areas that impact drug quality. The program is innovative and unique in offering in-depth, hands-on learning provided by full-time research faculty with both academic and industry experience. The student will gain valuable experience in pharmaceutical analytical instrumentation, documentation, GMP compliance, auditing, technical writing and quality assurance processes and procedures.
Pharma quality assurance remains extremely important and specialists in this field will continue to be needed, because of automation, more tasks that once fell to quality assurance engineers can be handled by production workers. There are probably more opportunities in other sectors of the economy, particularly in health care where quality assessment is a relatively new idea.
At the end of the course a student shall be expected to:
- Learn the requirements of quality assurance, compliance, and good manufacturing practices applicable to the regulated pharmaceutical industry
- Understand the unique aspects of documentation and its importance to quality work including industry specific concepts such as deviations, change control, out-of-specification, risk assessment, and corrective and preventative actions
- Acquire skills and knowledge that will help them gain employment in the regulated pharmaceutical industry. Additionally, their knowledge of this area would provide skills transferable to other industries with quality and compliance requirements
- Learn variety of topics related to the up-to-date regulations, analytical monographs, working knowledge of analytical instrumental techniques (HPLC, UV-Vis, FT-IR, TLC, GC and dissolution), computerized integrators and troubleshooting techniques in the pharmaceutical area
- Gain knowledge about quality system and Good Documentation Practices (GDPs), GMP, GLP, ICH, SOPs and principles of product complaints, product recall, returned goods, change control and CAPA
- Learn how to manage validation protocol, batch documents and investigation report and be familiar with facilities audit
- Quality assurance technicians or analysts
- Quality assurance or control managers
- Quality Researcher
- Quality Assurance Executive
- Quality Assistant
- Regulatory Executive