Qualification requirements for a GMP inspector

• availability of higher education in one of the following specialties: pharmacy, pharmaceutical technology, chemistry, chemical technology, biology, biotechnology;
• experience in the medicines manufacture, quality control, quality management (assurance) or the development of medicines, or experience in the field of licensing and state supervision (control) over the activities of business entities medicines manufacture for at least 3 years;
• the inspector must know the guidance materials that determine the direction of development of the relevant field of activity, namely: European and national legislation in the field of production and state control of medicines (GMP) and good distribution practice (GDP);
• fluent in Ukrainian;
• English language proficiency is desirable.

Personal qualities of a GMP-inspector:

The following personal qualities are desirable for a potential GMP inspector candidate:

• truthfulness;
• impartiality;
• tact in communication;
• observation.

Tasks and responsibilities:

• conduct a technical expertise of the conditions for the medicines manufacture in order to confirm the compliance of the medicines manufacture with GMP requirements on behalf of the The State Service of Ukraine on Medicines and Drugs Control.

Contacts for appeal

Vitalii, +38-044-272-57-98; v.khasanov@clab.com.ua