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Mikhail Nikitin Location
Oakville, ON, CA
Mikhail Nikitin Work
2018 -now Research and Development QA @
2014 -2018 Manager, Research and Development QA, Corporate Quality and Compliance @
2013 -2014 Lead Manager Quality Operations @
2010 -2013 QA Associate @
2002 -2010 QA Specialist @
Mikhail Nikitin Education
Saint-Petersburg State Academy of Veterinary Medicine
Mikhail Nikitin Skills
Lean Manufacturing
CAPA
Validation
Technology Transfer
FDA
GMP
GxP
Root Cause Analysis
Biotechnology
Quality Assurance
Supply Chain
Pharmaceutical Industry
Clinical Development
Computer System Validation
eCTD
Leadership
Software Documentation
Quality System
Continuous Improvement
Cleaning Validation
Clinical Trials
Deviations
GLP
SAP
Cross-functional Team Leadership
Change Control
Sop
Regulatory Submissions
5S
Six Sigma
Regulatory Affairs
Trackwise
Manufacturing
Process Improvement
GCP
21 CFR Part 11
Change Management
Vaccines
Regulatory Requirements
V&V
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
Good Clinical Practice (GCP)
Corrective and Preventive Action (CAPA)
Verification and Validation (V&V)
SAP Products
Business Process Improvement
Good Laboratory Practice (GLP)
Quality Management
Packaging
Regulations
Good Laboratory Practice Glp
Test Planning
Verification And Validation V&V
Good Clinical Practice Gcp
Corrective And Preventive Action Capa
Compliance
Contract Manufacturing
Testing
Risk Management
Cross Functional Team Leadership
Microsoft Excel
Customer Service
U.S. Food And Drug Administration Fda
Fda Regulations
Standard Operating Procedure Sop
R&D
u.s. Food and Drug Administration
Standard Operating Procedure
Good Clinical Practice
Corrective and Preventive Action
Verification and Validation
Good Laboratory Practice
Mikhail Nikitin Summary
Mikhail Nikitin, based in Oakville, ON, CA, is currently a Research and Development QA at Taro Pharmaceuticals. Mikhail Nikitin brings experience from previous roles at Apotex Inc., Novartis and Contract Pharmaceuticals Limited. Mikhail Nikitin holds a Saint-Petersburg State Academy of Veterinary Medicine. With a robust skill set that includes Lean Manufacturing, CAPA, Validation, Technology Transfer, FDA and more. Mikhail Nikitin has 2 emails on RocketReach.
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