olga blokhina

gcp and gvp qa manager

About

MD. GCP and PV auditing. 18 years in pharmaceutical industry, including 12 years in quality management. Specialties: GCP, GVP, QA, audit (Investigational sites, local affiliates, vendors, license partners, process), inspection facilitation, training and mentoring, quality management system, due diligence. Particular interest in the area of pharmaceutical company inspection readiness. Dear colleagues, if you want to connect, please write why you are interested to be in touch with me, otherwise I will not accept your invitation.

Country

germany

City

aachen

Industry

pharmaceuticals

Skill

gcp, clinical trials, ich gcp, clinical research, clinical monitoring, ctms, pharmaceutical industry, sop, pharmacovigilance, regulatory submissions, clinical development, cro, oncology, clinical operations, fda, drug development, therapeutic areas, clinical data management, regulatory affairs, edc, 21 cfr part 11, protocol, medical affairs, ind, clinical trial management system, neurology, standard operating procedure, good clinical practice, infectious diseases, hematology, medical writing, cardiology, u.s. food and drug administration, clinical trial management, quality management, quality assurance, corrective and preventive action, auditing, gvp auditing, gcp auditing, 21 cfr

Experience

cra

johnson & johnson

2002-1 - 2004-5 · 2 yrs 5 mos

project manager

johnson & johnson

2004-5 - 2006-7 · 2 yrs 3 mos

Full-cycle trial management on the country level; Coaching of CRAs.

quality and compliance manager russia, ukraine, turkey and israel

johnson & johnson

2009-11 - 2015-5 · 5 yrs 7 mos

Management of clinical trials quality in the region (including local operating companies inspections readiness, vendor selection, investigational sites and clinical operations training, procedural support). Audit of clinical trials sites and vendors; document audit.