The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Specialist of Department for Pharmaceuticals Production Inspection

Functional responsibilities:

  1. Conducting on-site inspections of finished dosage forms manufacturers, API manufacturers, whose production is realized outside the Russian Federation territory (foreign manufacturers), on compliance with the requirements of Good Manufacturing Practice rules.
  2. Expertise of pharmaceutical quality system documentation, quality management system. Preparation of reports on the inspection results. Participation in preparation of management documentation sections of the QMS department.
  3. Drawing up management documentation sections of the QMS department, participating in self-inspections.
  4. Participation in educational activities, conferences, seminars, trainings.
  5. Readiness for frequent business trips.

Key requirements:

  1. Education - higher education in one of the following specialties (training fields): biology, biotechnology, clinical medicine, radiation, chemical and biological defense, pharmacy, basic medicine, chemical technology and chemistry.
  2. Knowledge of foreign languages ​​– preferably.
  3. Preferred work experience - experience of at least 5 years in production and/or control, quality area. Knowledge of Good Manufacturing Practice rules; medicines circulation system, knowledge of GMP (GxP) rules (EU, FDA, WHO), knowledge and practical experience of validation and qualification of technological and laboratory equipment, engineering systems, clean environments and premises, validation of sterile production, including aseptic processes, computerized systems.

Working conditions:

  • Five-day working week with two days-off (Saturday, Sunday): Monday – Thursday from 9.00 to 18.00, Friday – from 9.00 to 16.45.
  • Employment in accordance with the Labor Code of the Russian Federation.
  • Full-time work.
  • Continual improvement of professional knowledge level.
  • A decent level of salary.