Arkadi Krainev
Sr. Manager, QA Engineering at Mizuho OSI
- Role
- Sr Manager, Qa Engineering at Mizuho OSI
- Location
- Fremont, CA, US
- LinkedIn followers
- 500 followers
About Arkadi Krainev
OVERVIEW: Accomplished regulated industry professional with over 20 years of experience working for food, biotech, pharmaceutical and medical device companies, including 17 years in leadership positions. Successful track record of leading cross-functional teams in development, process improvement and quality enhancement initiatives. Consulting for subjects of Quality Management Systems and Regulatory Affairs.
Experience
Sr Manager, Qa Engineering
Jan 2022 — Present · Union City, CA, US
For 2022, adding managing all aspects of software development lifecycle for automated systems used for quality data and related Computer System Validation (CSV) projects. Implemented electronic CAPA (2023) and Quality Deviation (2024) processes.
Education
The University of Kansas
Postdoctoral, Biochemistry
1992 — 1998
Novosibirsk State University (NSU)
MS, Chemistry
1977 — 1982
Tohoku University
Postdoctoral, Biochemistry
1991 — 1992
Novosibirsk Institute of Bioorganic Chemistry
Ph.D., Biochemistry
1984 — 1988
Skills
- Iso
- Continuous Improvement
- Statistics
- Analytical Chemistry
- Quality Management
- Hplc
- Design Control
- Medical Devices
- Capa
- Iso 9000
- Cross-Functional Collaborations
- Biotechnology
- Usp
- Iso 13485
- Assay Development
- Fmea
- Design of Experiments
- Manufacturing
- Quality Control
- Gmp
- Quality System
- V&V
- Ftir
- Cmc
- 21 Cfr Part 11
- Computer System Validation
- Quality Assurance
- Supplier Quality
- Validation
- Jmp
- Auditing
- Lims
- Data Analysis
- Gxp
- Chemistry
- Biochemistry
- R&D
- Analysis
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