Back
PwC brand and Hyderabad metro increase applicant density, but CSV specialization reduces generalist competition.
Role requires GxP/CSV regulatory expertise specific to pharma and life-science environments, limiting transferability.
Mandatory CSV, GxP, and FDA Part 11 experience with explicit 4-12 year requirement raises screening strictness.
Login to See Your Match Score
Create a free account or log in to unlock your CV match score across:
Own execution of Computer System Validation (CSV) activities including authoring validation deliverables such as Validation Plans, User Requirement Specifications, Functional Specifications, Risk Assessments, and Validation Summary Reports.
Perform manual testing including Positive/Negative, Regression, Smoke, and Sanity testing, defect tracking and reporting, aligned with SDLC and STLC methodologies (Waterfall, Agile, V model).
Ensure compliance with industry regulations including GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles, including managing Change Control, Deviation Management, CAPA, and Periodic Review processes.
4 to 12 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor of Technology or Bachelor of Engineering degree mandatory.
Knowledge of SDLC methodologies such as Waterfall, Agile, and V model of CSV.
Experience with CSV regulatory guidelines - GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.
Experienced in end-to-end Computer System Validation within regulated environments with focus on compliance and quality assurance.
Skillful in manual testing and defect management aligned with multiple SDLC models and validation standards.
Capable of producing detailed validation documentation and managing compliance processes such as Change Control, Deviation Management, and CAPA.