Arkadi Krainev

Sr Manager, Qa Engineering @Mizuho OSI

Fremont, CA, US
EMAILS
a•••••••@mizuhosi.com
MOBILE NUMBERS
+15•••••••47

Signup · Get unlimited contacts

WORK HISTORY

Jan 2022 — Present

Sr Manager, Qa Engineering @Mizuho OSI

View department →

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

1992 — 1998

The University of Kansas

Postdoctoral, Biochemistry

1977 — 1982

Novosibirsk State University (NSU)

MS, Chemistry

1991 — 1992

Tohoku University

Postdoctoral, Biochemistry

1984 — 1988

Novosibirsk Institute of Bioorganic Chemistry

Ph.D., Biochemistry

SKILLS

IsoContinuous ImprovementStatisticsAnalytical ChemistryQuality ManagementHplcDesign ControlMedical DevicesCapaIso 9000Cross-Functional CollaborationsBiotechnologyUspIso 13485Assay DevelopmentFmeaDesign of ExperimentsManufacturingQuality ControlGmpQuality SystemV&VFtirCmc21 Cfr Part 11Computer System ValidationQuality AssuranceSupplier QualityValidationJmpAuditingLimsData AnalysisGxpChemistryBiochemistryR&DAnalysis

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.

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.