Excel, Quality Assurance, Powerpoint, Supplier Management, Office Word, Microsoft Office Suite

Data Analysis and Reporting Tools, Root Cause Analysis, 6-sigma Green Belt, Ppap, 7QC Tools, Supplier Quality Management, Sap Mm Module

MDSAP, Iso 13485, 21 CFR Part 820, work instructions, Sops, Document Control, Internal Audit, Root Cause Analysis, Capa

Iso 27001, Agile Software Development, IVDR Annex 11, IVD development validation and regulatory approval, Iso 13485, 21 CFR Part 820, EU MDR, Clinical NGS interpretation reporting, Part 11, analytics for drug discovery and development, AI-powered multimodal data harmonization

FDA regulations e.g. 21 CFR Part 11, EMA EU CTR Annex 11, GxP frameworks GCP GMP GLP GCLP, Data review expertise across computerized systems including LIMS, Understanding of Audit trails metadata and system validation, Data governance frameworks, ICH-GCP E6 R2 R3

Client SOP, 7QC tools, Microsoft Office 360 suite, Root Cause Analysis, Quality Concept

Attention To Detail, Basic Audit Techniques, Problem-solving, Communication, IT Proficiency, Analytical Skills, Quality management systems, Ethics Compliance, ISO 9001 standards, Quality Management, Organizational Skills

Agile Development Methodologies, Software Testing, Automation Testing Tools, Jira, Quality Assurance, Azure DevOps, ClickUp, API testing using Postman

Ms Office, Open TWINS, Analytical Thinking, Financial and Regulatory Controls Compliance Frameworks, Quality Assurance Tools Methodologies, Reinsurance