>6 years in the Pharmaceutical industry (Production and Quality Assurance dept. at
R-Pharm and
Moscow Endocrine Plant).
Expert in GMP documentation, validation files, and regulatory submissions.
Responsible for:
- Preparing GMP inspection applications (Minpromtorg, Rosselkhoznadzor)
- Communicating with regulatory authorities
- Assessing site readiness (validation & documentation)
- Managing inspection-related documentation and CAPA processes
- Ensuring compliance with current GMP legislation (703n, Decision 77, PIC/S, EMA)