Nalinee Wadekar available

Nalinee Wadekar

Computer System Validation Quality Assurance and Testing

available
Profileimage by Nalinee Wadekar Computer System Validation Quality Assurance and Testing from
  • Freelancer in
  • Graduation: not provided
  • Hourly-/Daily rates: 42 $/hour 210 $/day
    Negotiable
  • Languages: English (Limited professional) | Hindi (Limited professional)
  • Last update: 03.12.2018
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
REFERENCES
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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