Qualandre was created by Philippe Andre, a Belgian pharmacist active as a GMP auditor in China since 2009. Our main office is in Hangzhou, China.
GMP audits are our sole activity. We conduct dozens of them each year in China, India, Japan, Korea and other Asian countries. Their scope covers active pharmaceutical ingredients, intermediates, chemical specialties, medicinal products, vaccines, medical devices, pharmaceutical distribution... Our main standards are the ICH Guidelines and the European GMP Guide. We have a strong focus on manufacturing controls, science-based validation and data reliability. We are looking for more GMP auditors who have
ability to write GMP audit report in English

ability to communicate with foreign customers

ability to learn about international pharmaceutical regulations

and willingness to travel often.
In this position, you will travel two or three times per month to a pharmaceutical factory in China, to audit their quality management and compliance to good manufacturing practice on behalf of its European and American customers. You will write your observations in a detailed report, and review the factory’s response to your observations. You will keep up-to-date with pharmaceutical regulations. In addition to a technical background in pharmaceutical or chemical sciences, you will be able to distinguish the relative importance of each deficiency observed during your audits. Your work experience in pharmaceutical quality management or production would be an advantage.