A Career Choice in Biopharmaceutical Quality Assurance
Biopharmaceuticals are proteins and nucleic acids that are used for therapeutic or in vivo purposes. Many biopharmaceuticals are derived through life forms involving transgenic organisms.
With the introduction of cloning, nanotechnology and genetic engineering entering the biopharmaceutical industry, the need for quality assurance is greater than ever. As technology moves forward, the need for highly trained quality control personnel becomes a necessity.
Quality Assurance within the Manufacturing Sector
As of 2009, the biopharmaceutical industry does not have a standard quality control process in place. The current quality process is based on analysis to measure the quality after the drug has been created. Biopharmaceutical companies spend millions of dollars each year to produce a drug that they do not know will work. After the drug has gone through research and development, manufacturing, and analysis, then the company will find out if their efforts paid off.
A fifteen-company project has started in Ireland to start the quality control process in the early stages of the manufacturing process.
According to Dr. Keith O’Neill, Enterprise Ireland’s Director of Lifescience Commercialisation, “the key benefit to the companies involved will be access to the next generation of process control tools to enable safe and efficient production of biopharmaceutical drugs. By investing in the development of these advanced technologies, Ireland is positioning itself to lead the next wave of biopharmaceutical manufacturing and ensure our competitiveness in this sector.”
Why Choose Biopharmaceutical Quality Assurance
Biopharmaceutical products are manufactured in several different forms; powders, creams and lotions are just a few examples. With the variance of products being manufactured under a wide variance of conditions, quality control is a must for the biopharmaceutical industry. A biopharmaceutical product has eight quality dimensions to consider; performance, secondary features, durability, aesthetics, perceived quality, service, conformance and reliability.
Biopharmaceutical Quality Assurance is focused on basic research, commercial research, and standardized testing, including forensic human identification, paternity testing and food testing.
Biopharmaceutical Quality Assurance Manager Requirements
A Bachelor’s degree to a PhD is required for the management levels of Quality Assurance. Companies will also require 5 to 10 tears of quality assurance experience. Individual companies may require specific software background, specific analytical skills, and of course, regular management skills are necessary. If considering a position in this field it is a good idea to have some medical background experience and a desire to learn upcoming technology.
Resources
Irish biopharmaceutical industry gets 2.3 million research boost
The sources of quality in the pharmaceutical industry
Biopharmaceutical Company announces asthma treatment collaboration
