Computer system validation

From 4 to 9 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

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

Role:Software Development - Other

Salary: Not Disclosed by Recruiter

Industry:IT Services & Consulting

Functional Area:Engineering - Software & QA

Role Category:Software Development

Employment Type:Full Time, Temporary/Contractual


UG:Any Graduate

Company Profile


Greetings from IDESLABS. About IDESLABS Summarised our services for your perusal. Consulting Services : Predominantly into resourcing for both contract and permanent positions 30 plus strong recruiter base based out of India 150+ resources working at multiple customer locations Partner with large IT houses such as NTT DATA, DXC, Tech Mahindra, etc Training Services: We provide Online Training for Individual Consultants and Corporate Training on Various Trending Technologies We have 9000+ Trainer ecosystem 900 Plus courses on various trending technologies, Delivered 45000 Plus of training programs across Geographies Delivering virtual training to 150 + Professionals on a monthly basis across technologies Training Partner for large corporations such as Tech Mahindra, Infosys, Mylan, NTT DATA and etc Presence in India, the US, and the UK Support Services: More than 30 plus IT professionals signing up on a monthly basis for a period of 1 month to 12 months Launching Shared Support Services in various technologies in SAP, JAVA, Cyber Security, IDM Tools and etc..
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