Home
Jobs

IN_Associate_CSV_ITRA_Advisory_Gurgaon

5 - 10 years

8 - 12 Lacs

Posted:2 months ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

Having 510 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance. Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV. Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis) \ Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. Knowledge of Change Control, Deviation Management, CAPA and Periodic Review. Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR)

Mock Interview

Practice Video Interview with JobPe AI

Start Manager Internal Audit Interview Now

My Connections PwC Service Delivery Center

Download Chrome Extension (See your connection in the PwC Service Delivery Center )

chrome image
Download Now
PwC Service Delivery Center
PwC Service Delivery Center

IT Services and IT Consulting

New York NY

10001 Employees

1413 Jobs

    Key People

  • Tim Ryan

    U.S. Chairman and Senior Partner
  • Dawn P. O’Reilly

    Chief Operating Officer

RecommendedJobs for You