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Coretek Labs India
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Computer System Validation Engineer

Computer System Validation Engineer

Coretek Labs India

3 - 6 years

10 - 15 Lacs

hyderabad

Posted:1 week ago| Platform:

Apply

Skills Required

computer system validation pq oq fda csv iq

Work Mode

Hybrid

Job Type

Full Time

Job Description

Job Title:

Computer System Validation (CSV) Specialist Regulatory Compliance & QA

Location:

Hyderabad

Experience:

3 to 6 Years

About the Role:

MNC is hiring

Key Responsibilities:

Identify/manage regulatory risks (GxP, cGMP, FDA, 21 CFR Part 11)
Author validation strategies, protocols, and reports (end-to-end CSV required)
Execute IQ, OQ, PQ in compliance with cGMP
Work with cross-functional teams: R&D, QA, IT, Manufacturing, Engineering
Validate systems in Agile SDLC environments
Review validation lifecycle documentation
Support Change Management, CAPA, Deviations, and Periodic Reviews

Must-Have Skills:

36 years of hands-on
CSV experience
Agile SDLC validation experience
Tools:
JIRA, HP ALM, QTest, SAP, ServiceNow, Solution Manager, ValGenesis, Veeva
Familiarity with quality processes: Change Mgmt, CAPA, Deviations, etc.

Apply Now:

mani@coretek.io

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