Shifali A
Validation Specialist @ClinChoice
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WORK HISTORY
Validation Specialist @ClinChoice
EDUCATION
Andhra University
Master of Science - MS, Microbiology, General
St. Joseph's College for Women (Autonomous), Visakhapatnam
Bachelor of Science - BS, Biotechnology, Biochemistry, Chemistry
Sri Chaitanya College of Education
Board of Secondary Education, Core
Clinosol
PG Diploma , Clinical Research , Clinical Data Management
Sri Chaitanya Junior College, Hydernagar
Board of Intermediate, BiPC
ABOUT SHIFALI A
Detail-oriented CSV Analyst with 2+ years of experience in ensuring compliance with GxP, 21 CFR Part 11, and delivering validated, audit-ready computerized systems. Proficient in the full validation lifecycle (IQ, OQ, PQ), risk assessments (FMEA), and quality management processes (CAPA, Deviations, Change Controls). Skilled in managing validation for web and mobile applications, including Clinion EDC, CTMS, IWRS, ePRO, eConsent, and eSource.Core Skills:* CSV Expertise: Validation lifecycle, GAMP5, Traceability Matrix *Regulatory Compliance: GxP, 21 CFR Part 11, FDA, and EMA standards *Tools & Methodologies: Azure DevOps, Power BI, JIRA, Agile & Waterfall *QMS Management: CAPA, Deviations, Change Controls *Clinical Trial Support: CRF design, edit checks, and clinical data management Certifications- Good Clinical Practices (NIDA Clinical Trials Network)- Advanced PG Diploma in Clinical Data Management and Research With a proven track record of delivering validated systems, collaborating with cross-functional teams, and improving system efficiency, I am passionate about ensuring compliance excellence in Clinical Research and Software domains. Let’s connect to explore opportunities in delivering compliant, reliable systems.
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