Computer Systems Validation Analyst/ CSV Analyst Client Jobs in Hyderabad at Siera IT Services Private Limited

Last Updated: Aug 15, 2021 05:10 IST


Company Name
Siera IT Services Private Limited
Job title
Computer Systems Validation Analyst/ CSV Analyst Client
5-10 Years
Not Mentioned

Job Profile

Title: CSV Analyst/ omputer Systems Validation Analyst
Experience: 5 to 10 Years.
Client Location: Bangalore/ Hyderabad

Job Description:

CSV Compliance Assessments and determining the risk level
As applicable, prepare a milestones of Val deliverables for a Project
During CSV Concept and Planning Phase, as applicable, draft/review and approve various plans as CSV Lead -
Validation Plan
Data Integrity/Migration
Security Plan
Business Continuity Plan and Disaster Recovery Plans
Training Plan
During Requirements, Design and Build Phase - Coordinate, Review and approve
User/Functional/System/Data Migration Requirements
Functional Risk Assessment at Requirement Level
Protocols (pre and post review and approvals) - For Installation/Operation/Performance/Data Migration Qualification
Config/Design specification documents
Requirement Traceability Matrix
Standard Operating Procedures on system intended use and system administration including Data Migration
During Validation Phase - draft, collaborate, review and approve
Qualification protocol execution and reporting - IQ, OQ, PQ, DMQ in GxP sensitive environments (as applicable)
Review objective evidence at protocol level and sign-off
Testing Summary Reports
During CSV Release and Maintenance Phase - draft, collaborate, review and approve
Qualification protocols execution in Prod - IQ, PQ, DMQ
Review objective evidence at protocol level and sign-off
Validation Summary Report
Qualification/Validation of tools/utilities interacting with GxP sensitive environments
Executing CAPA procedures, drafting and approving deviation logs and keeping artifacts audit-ready in MasterControl, ALM and ServiceNow tools
Review and draft standard operating procedures the system and integrated tools refresh, upgrades, patching etc.
Project CHG management - CSV support to maintain the validated state
Key Skills:  Expert with ALM and ServiceNow Tools, knowledge of MasterControl would be a bonus

If interested share your updated resume to [email protected]

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Key skills
Csv, Computer System Validation, Analyst
IT/ Computers - Software
Computer Systems Validation Analyst/ CSV [email protected] Client Location
Last Date

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