The Role of Quality Assurance in the Pharmaceutical Industry
Career Path : Healthcare
Quality control is an important stage in any business. A manufacturer needs to regularly check his products before shipping to clients to make sure there are no defects. A service industry often asks clients for evaluations after the completion of a job to make sure its employees are making good on the company’s performance promises. In some of these cases, negative results can have only minor consequences, like a quick adjustment in the manufacturing process or further training for an employee. But there are some industries where quality control is extremely crucial and where the consequences for quality negligence can be very serious, and even harmful. These are the healthcare industries, and specifically, the pharmaceutical industry.
Making sure the drugs and medicines produced by pharmaceutical companies have undergone rigorous quality assurance, testing, and follow-up procedures is a career in itself that is taught in many schools and universities. This kind of education combines much classroom theory with technical hands-on experience, often placing a special emphasis on the utilization of the latest technologies in pharmaceutical manufacturing and testing. But aside from technology, no program is complete without the professional expertise of its teachers, which should include a mix of professionals from pharmaceutical industries, biopharmaceutical industries, and even chemists.
A degree inÂ pharmacy quality controlÂ can open up several different career opportunities in various facilities or companies. Here are just a few:
Become an analyst working with raw chemical materials or manufactured products ensuring they meet expected quality standards through various stages of manufacturing. This requires the recording and interpretation of data. Or become a laboratory chemist and work more closely with the development of new products, as well as new methods for testing and maintaining quality assurance.
Work with local and international organizations to guarantee products adhere to certain standards. Prepare submissions to regulatory bodies, reviews submission results, and resolves problems where results fail to meet certain guidelines. One can work either in a pharmaceutical company, for an independent regulatory firm that helps companies, or even for the regulatory bodies themselves.
Focus primarily on following company policies and procedures to make sure thatÂ quality assurance and quality controlÂ protocols are being maintained. While one can work for an independent auditing firm, many pharmaceutical companies employ internal auditors as an extra guarantee that laws and regulations are being upheld. The main difference between regulatory and auditing work is that the former deals with the product while the latter with the process.
While it is an important and wonderful thing that pharmaceutical companies are constantly developing new drugs and medicine to help people, we must always remember that unchecked development can result in problems down the line. This is why innovators need to work with quality control checkers to guarantee responsible innovation.
Visit the Academy of Applied Pharmaceutical Sciences (AAPS) Inc. for more information onÂ pharmaceutical quality assurance.