Quality Engineer

Moscow

Full day

Any questions about this vacancy?

Send your question by email to hr@promomed.pro

We are PROMOMED Group of Companies, an innovative Russian pharmaceutical company engaged in the production and promotion of prescription and over–the-counter drugs in several therapeutic areas: endocrinology, infectious diseases, rheumatology, neurology, urology, cardiology, gynecology and others.

The main asset of the Promomed Group is its employees.One of our values, cooperation and development, reflects the culture and atmosphere in the company.
We value openness to new things, support those who want to learn, and we sincerely believe in what we do.

We invite you to join our team as a quality engineer

Responsibilities

  • Development of FGC procedures
  • Maintaining quality assurance systems (changes, suppliers, audits)
  • Conducting quality audits (self-inspections) of the site, contract manufacturers, suppliers of raw materials and packaging materials
  • Preparing the site for licensing, certification, and external quality audits
  • Coordination of the internal documentation of the site
  • Development and organization of the risk analysis development process

Requirements

  • Knowledge of the laws of the Russian Federation, Orders, Resolutions of the Government of the Russian Federation covering the sphere of drug circulation, and other regulations of the Ministry of Health, the Ministry of Industry and Trade of the Russian Federation, Roszdravnadzor, and Rospotrebnadzor;
  • Federal Law No. 61-FZ of 12.04.2010 "On the Circulation of Medicines";
  • Decision of the Council of the Eurasian Economic Commission No. 77 dated 03.11.2016 "On approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union".
  • ICH Q9 «Quality risk management»
  • ICH Q10 «Pharmaceutical quality system»
  • Have higher specialized education (biochemical, biological, medical, veterinary, biotechnological, microbiological or similar)
  • Knowledge of English (Pre-intermediate and higher)
  • Basic PC skills

Working conditions

  • Official recruitment, indefinite employment contract
  • White salary (we will discuss your wishes by phone)
  • Opening hours are Mon-Fri, 9-18
  • Social.Package: VMI with a good selection of clinics and dentistry
  • Mobile communication
  • A guide with a Western approach and standards

If you want to become part of our team, send your resume indicating your salary expectations

Any questions about this vacancy?

Send your question by email to hr@promomed.pro