When applying for a pharmaceutical product manufacturer licence, what qualifications are required of the head of the Quality Control (QC) department, in addition to the AP?

In the application for and operation of a pharmaceutical product manufacturer licence, the Head of the Quality Control (QC) department has a vital role, and their qualifications directly affect whether products can consistently meet quality standards. Under PIC/S Good Manufacturing Practice (GMP), the QC Head must be independent of the production department and report directly to management. Qualification requirements generally include: 1) a university degree in pharmacy, chemistry, biology, microbiology or a related scientific field; 2) several years’ practical experience in pharmaceutical quality control and familiarity with analytical techniques and operating instruments such as HPLC and GC; 3) a thorough knowledge of GMP regulations, particularly requirements relating to laboratory management, sampling, stability testing, documentation and deviation investigations; and 4) the ability to manage a QC team and ensure that all tests are accurately performed using validated methods.