Experience in Business Analysis, Quality Analyst, Good Documentation Practices (GDP), Computer System Validation, Validation Methodologies, Risk Management & Compliance in Pharmaceutical Industry
Prepare the project for Audit readiness.
Experience in GAMP5 and FDA regulations 21CFR Part 11, Track Wise, and Change Request.
Experience in Database Testing, ETL Testing, SQL.
Experience in performing Manual and Automated testing using Quick Test Professional QTP, Quality Center, PDOCs, JIRA, and IPRM.
Excellent understanding of all phases of Software Development Life Cycle SDLC, STLC, Agile, Waterfall, V model and Validation Life Cycle VLC, GRC and SCRUM based agile methodology.
Certificate in Software Testing Skills
Certificate in Life Sciences domain
Lean bronze- Six Sigma certified
PROJECT HISTORY
Worked for more than 6 years in Major US pharmaceutical company as GRC Constutant, Compliane & Audit.
TIME AND SPATIAL FLEXIBILITY
Current Location: Mumbai- India.
Flexible to travel to other locations (Onsite/Offshore)
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