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Nalinee Wadekar

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Last update: 03.12.2018

Computer System Validation Quality Assurance and Testing

Graduation: not provided
Hourly-/Daily rates: show
Languages: English (Limited professional) | Hindi (Limited professional)

Keywords

Skills

  • 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.

Local Availability

Only available in these countries: India
Current Location: Mumbai- India.
Flexible to travel to other locations (Onsite/Offshore)
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