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SQA - CSV Validation Engineer - Princeton, NJ (Need Locals / Onsite) at Princeton, New Jersey, USA
Email: [email protected]
Role: SQA CSV Validation Engineer

Location: Princeton, NJ ( Need Locals / Onsite)

Duration: 12+ Months

Job Description:

Experience in Tealium

JavaScript and React
experience.

Experience in Tagging on a website

Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.

You should have excellent understanding of
21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.

Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems

Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation

Requirement Specification document review and approvals

System Implementation Plan Review

System Implementation Summary Report Review

Review and Pre-Approve ST/UAT Test Scripts in ALM

Create, Update RRA (Regulatory Risk Assessment) and obtain approvals

Post Execution Review and Post Approvals in ALM

gR Implementation Approvals

Retirement Plan Revew

Retirement Summary review Deliverables:

Requirement document

Validation/Test Plan

Requirement Traceability Matrix

Change Requests

Impact assessment document

Test/Validation Summary Report

Thanks & Regards

Manoj Vemula

Email
: [email protected]

LinkedIn:
linkedin.com/in/manoj-vemula-52a356209

5490 McGinnis Village Place Suite 237 Alpharetta GA 30005

Web
:

www.nexwaveinc.com

USA 
II
INDIA 
II 
Canada

II
 UK
II
 Germany

Keywords: Georgia New Jersey
SQA - CSV Validation Engineer - Princeton, NJ (Need Locals / Onsite)
[email protected]
[email protected]
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Tue Jul 30 20:46:00 UTC 2024

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Location: Princeton, New Jersey