Svit M.
M.S. in Medicine, RN
- Role
- Qa, Consultant at Robert Half
- Location
- Salt Lake City, UT, US
- LinkedIn followers
- 500 followers
About Svit M.
QA & PM | Quality Metrics & KPIs | Data Analysis | Continuous Improvement
Experience
Qa, Consultant
Oct 2023 — Present · Berkeley, CA, US
Supported lot disposition by reviewing batch records, QC data, CoCs/CoAs, validation reports, and other release documents for data integrity, traceability, and compliance. Provided QA support to Manufacturing, QC, and Facilities by triaging issues, assessing impact, and recommending corrective actions. Escalated critical deviations and quality concerns to supervisors. Collaborated with internal teams and CDMOs to resolve deviations, missing data, and observations; escalated as needed. Supported change controls, deviations, OOS, CAPAs, and other quality system activities, ensuring complete and audit-ready documentation. Conducted internal training sessions for staff on developing Key Performance Indicators (KPIs) and performing comprehensive batch record reviews. Assisted in internal and external audits, including logistics, documentation, and CAPA tracking. Reviewed, drafted SOPs and QA documents to align with current practices and regulations. Maintained QA metrics and Excel-based tracking tools; analyzed data and created charts for performance visibility. Promoted GMP/GDP compliance and continuous improvement across teams. Represented QA in cross-functional projects and CDMO interactions, providing compliance guidance. Identified trends, recurring issues, and improvement opportunities. Documented QA meetings, action items, and follow-ups.
Education
Kharkoiv State Medical University
Master's degree, Infectious diseases
1998 — 2004
Kharkiv State Medical University
Residency, Infectious Diseases Residency Program
2005 — 2007
City Business School
MBA
2020 — 2026
Medical Professional College #1
Diploma in Nursing
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